Our History

Alexion Timeline: A Commitment to Breakthrough Innovation

Since our founding in 1992, Alexion has given hope to people who had none and shined a light on those who felt isolated and alone. We have remained steadfast in our pursuit of groundbreaking innovation, and have delivered solutions to challenges that once seemed impossible. Here are some of the milestones throughout our history.

Company Milestone Product Milestone Awards and Recognition
  • 2019
    SOLIRIS is approved in the U.S. for the treatment of adult patients with anti-aquaporin-4 (AQP4) antibody positive neuromyelitis optica spectrum disorder (NMOSD)
    Alexion and Zealand Pharma announce collaboration to discover and develop peptide therapies for complement-mediated diseases
    ULTOMIRIS is approved in Japan and the EU for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
    Alexion and Affibody announce partnership to co-develop anti-FcRn Affibody molecule
  • 2018
    ULTOMIRIS is approved in the U.S. for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH)
    Alexion acquires Syntimmune, a clinical-stage biotechnology company developing antibody therapeutics targeting the neonatal Fc receptor (FcRn)
    Alexion and Dicerna partner to discover and develop RNA interference (RNAi) therapies for complement-mediated diseases
    Alexion and Complement Pharma partner to co-develop pre-clinical complement inhibitor for neurodegenerative disorders
    Alexion acquires Wilson Therapeutics, strengthening its pipeline and expanding its focus on metabolic and neurologic disorders
    Forbes Logo
    Alexion is named one of the World's Most Innovative Companies by Forbes consecutively from 2012 to 2018
    Alexion’s data sciences work contributes to Rady Children’s Institute for Genomic Medicine scientists’ achievement of new GUINNESS WORLD RECORDS™ title for fastest genetic diagnosis
  • 2017
    SOLIRIS is approved in the U.S. and Japan for the treatment of adult patients with generalized myasthenia gravis (gMG) who are anti-acetylcholine receptor (AchR) antibody-positive and in the European Union for the treatment of refractory generalized gMG in adult patients who are anti-AchR antibody-positive
  • 2016
    KANUMA is approved as a treatment for patients with lysosomal acid lipase deficiency (LAL-D) in Japan
    Alexion receives 2016 Rare Impact Award from the National Organization for Rare Disorders (NORD®) and is named as Industry Innovation Honoree for the Company’s work in bringing STRENSIQ and KANUMA to market
    KANUMA receives 2016 German Prix Galien Award in the Orphan Product category
    Science names Alexion as a Top Employer in both 2015 and 2016
    Alexion initiates two Phase 3 clinical trials of ALXN1210 in complement inhibitor treatment-naïve patients with PNH and aHUS, and receives ODD for ALXN1210 for the treatment of patients with PNH from the EC
  • 2015
    STRENSIQ is approved as a treatment for patients with hypophosphatasia (HPP) in the U.S., EU, Japan and Canada
    KANUMA is approved as a treatment for patients with lysosomal acid lipase deficiency (LAL-D) in the U.S. and EU
    Alexion is named one of Fortune Magazine’s Fastest Growing Companies in 2011, 2012, 2014 and 2015
  • 2014
    SOLIRIS receives orphan drug designation (ODD) for multiple potential indications:
    • Prevention of delayed graft function (DGF) in renal transplant patients from the FDA, and prevention of DGF after solid organ transplantation from the EMA
    • Treatment of refractory myasthenia gravis (MG) from the FDA and EMA
    Alexion initiates multinational registration trials of eculizumab as a potential treatment for patients with NMO, MG and DGF
    Connecticut Magazine names Alexion one of the top workplaces in the state in both 2010 and 2014
  • 2013
    Asfotase alfa receives Breakthrough Therapy Designation from the FDA for the treatment of HPP
    SOLIRIS is approved as a treatment for patients with aHUS in Japan
    SOLIRIS receives orphan drug designation (ODD) for the treatment of neuromyelitis optica (NMO) from the FDA and EMA
  • 2012
    Alexion acquires asfotase alfa, the first potential treatment for patients with hypophosphatasia (HPP)
    New England Journal of Medicine publishes data from Phase 2 study of asfotase alfa in
    life-threatening HPP
    Alexion is added to the S&P 500 Index of leading global companies
    Alexion presented with the Partners in Progress Award from the National Organization for Rare Diseases (NORD®)
  • 2011
    The FDA and the EMA approve SOLIRIS as the first and only treatment for adult and pediatric patients with aHUS
  • 2010
    U.S. Green Building Council (USGBC) twice recognizes Alexion with LEED® Certification Awards for constructing, operating and maintaining interiors that meet the highest green building and performance standards
  • 2009
    SOLIRIS receives the Prix Galien France Award for Drugs for Rare Diseases
  • 2008
    SOLIRIS is first used as a treatment for patients with atypical hemolytic uremic syndrome (aHUS) in France and Germany
    SOLIRIS receives the Prix Galien USA Award for Best Biotechnology Product
  • 2007
    SOLIRIS receives approval from the FDA and European Medicines Agency (EMA) as the first and only treatment for patients with PNH
    Alexion honored with the Corporate Leadership Award from the National Organization for Rare Disorders (NORD®)
    Alexion earns the Award of Excellence from Connecticut United for Research Excellence (CURE)
  • 2005
    Second pivotal Phase 3 study of eculizumab in patients with PNH begins (SHEPHERD)
  • 2002-2004
    Pilot study with eculizumab commences in Leeds, England in paroxysmal nocturnal hemoglobinuria (PNH)
    New England Journal of Medicine publishes positive results from pilot study of eculizumab in 11 patients with PNH
    First pivotal Phase 3 study of eculizumab commences in patients with PNH (TRIUMPH)
  • 1996-1998
    First in-human clinical trial of eculizumab begins
  • 1992-1994
    C5 complement inhibitor development program commences

INDICATION & IMPORTANT SAFETY INFORMATION FOR ULTOMIRIS

INDICATION

ULTOMIRIS® is indicated for the treatment of adult patients with paroxysmal nocturnal hemoglobinuria (PNH).

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening meningococcal infections/sepsis have occurred in patients treated with ULTOMIRIS. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of ULTOMIRIS, unless the risks of delaying ULTOMIRIS therapy outweigh the risk of developing a meningococcal infection [see Warnings and Precautions for additional guidance on the management of the risk of meningococcal infection].
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the ULTOMIRIS REMS, prescribers must enroll in the program [see Warnings and Precautions]. Enrollment in the ULTOMIRIS REMS program and additional information are available by telephone: 1-888-765-4747 or at www.ultomirisrems.com.

CONTRAINDICATIONS

ULTOMIRIS is contraindicated in patients with unresolved Neisseria meningitidis infection.

WARNINGS AND PRECAUTIONS

Serious Meningococcal Infections

Risk and Prevention

Life-threatening meningococcal infections have occurred in patients treated with ULTOMIRIS. The use of ULTOMIRIS increases a patient’s susceptibility to serious meningococcal infections (septicemia and/or meningitis). Meningococcal disease due to any serogroup may occur.

Vaccinate for meningococcal disease according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations for patients with complement deficiencies. Revaccinate patients in accordance with ACIP recommendations considering the duration of ULTOMIRIS therapy.

Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of ULTOMIRIS. If urgent ULTOMIRIS therapy is indicated in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide patients with 2 weeks of antibacterial drug prophylaxis.

In clinical studies, 59 patients with PNH were treated with ULTOMIRIS less than 2 weeks after meningococcal vaccination. All of these patients received antibiotics for prophylaxis of meningococcal infection until at least 2 weeks after meningococcal vaccination. The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving ULTOMIRIS have not been established.

Vaccination reduces, but does not eliminate, the risk of meningococcal infections. In clinical studies, 3 out of 261 PNH patients developed serious meningococcal infections/sepsis while receiving treatment with ULTOMIRIS; all 3 had been vaccinated. These 3 patients recovered while continuing treatment with ULTOMIRIS.

Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if infection is suspected. Inform patients of these signs and symptoms and steps to be taken to seek immediate medical care. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Consider discontinuation of ULTOMIRIS in patients who are undergoing treatment for serious meningococcal infection.

ULTOMIRIS REMS

Due to the risk of meningococcal infections, ULTOMIRIS is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the ULTOMIRIS REMS, prescribers must enroll in the program.

Prescribers must counsel patients about the risk of meningococcal infection/sepsis, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccines.

Enrollment in the ULTOMIRIS REMS and additional information are available by telephone: 1-888-765-4747 or at www.ultomirisrems.com.

Other Infections

ULTOMIRIS blocks terminal complement activation; therefore patients may have increased susceptibility to encapsulated bacteria infections, especially infections caused by Neisseria meningitis but also Streptococcus pneumoniae, Haemophilus influenzae, and to a lesser extent,Neisseria gonorrhoeae. If ULTOMIRIS therapy is administered to patients with active systemic infections, monitor closely for signs and symptoms of worsening infection.

Monitoring Disease Manifestations after ULTOMIRIS Discontinuation

After discontinuing treatment with ULTOMIRIS, closely monitor for signs and symptoms of hemolysis, identified by elevated LDH along with sudden decrease in PNH clone size or hemoglobin, or re-appearance of symptoms such as fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), major adverse vascular event (including thrombosis), dysphagia, or erectile dysfunction. Monitor any patient who discontinues ULTOMIRIS for at least 16 weeks to detect hemolysis and other reactions. If signs and symptoms of hemolysis occur after discontinuation, including elevated LDH, consider restarting treatment with ULTOMIRIS.

Thromboembolic Event Management

The effect of withdrawal of anticoagulant therapy during ULTOMIRIS treatment has not been established. Therefore, treatment with ULTOMIRIS should not alter anticoagulant management.

Infusion Reactions

Administration of ULTOMIRIS may result in infusion reactions. In clinical trials, 3 out of 222 patients with PNH treated with ULTOMIRIS experienced infusion reactions (lower back pain, drop in blood pressure and infusion-related pain) during ULTOMIRIS administration. These reactions did not require discontinuation of ULTOMIRIS. Interrupt ULTOMIRIS infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

Adverse reactions reported in 5% or more of patients treated with ULTOMIRIS vs. Eculizumab was Upper respiratory tract infection (39% vs 39%), Headache (32% vs. 26%), Diarrhea (9% vs. 5%), Nausea (9% vs. 9%), Pyrexia (7% vs 8%), Pain in extremity (6% vs. 5%), Abdominal pain (6% vs. 7%), Dizziness (5% vs. 6%), Arthralgia (5% vs. 5%).

Serious adverse reactions were reported in 15 (6.8%) patients receiving ULTOMIRIS. The serious adverse reactions in patients treated with ULTOMIRIS included hyperthermia and pyrexia. No serious adverse reaction was reported in more than 1 patient treated with ULTOMIRIS.

One fatal case of sepsis was identified in a patient treated with ULTOMIRIS.

Please see full prescribing information for ULTOMIRIS, including Boxed WARNING, regarding serious and life-threatening meningococcal infections/sepsis.

INDICATIONS & IMPORTANT SAFETY INFORMATION FOR
SOLIRIS® (eculizumab)

INDICATIONS

Paroxysmal Nocturnal Hemoglobinuria (PNH)
Soliris is indicated for the treatment of patients with paroxysmal nocturnal hemoglobinuria (PNH) to reduce hemolysis.

Atypical Hemolytic Uremic Syndrome (aHUS)
Soliris is indicated for the treatment of patients with atypical hemolytic uremic syndrome (aHUS) to inhibit complement-mediated thrombotic microangiopathy.

Limitation of Use

Soliris is not indicated for the treatment of patients with Shiga toxin E. coli related hemolytic uremic syndrome (STEC-HUS).

Generalized Myasthenia Gravis (gMG)
Soliris is indicated for the treatment of generalized myasthenia gravis (gMG) in adult patients who are anti-acetylcholine receptor (AChR) antibody positive.

Neuromyelitis Optica Spectrum Disorder (NMOSD)
Soliris is indicated for the treatment of neuromyelitis optica spectrum disorder (NMOSD) in adult patients who are anti-aquaporin-4 (AQP4) antibody positive.

IMPORTANT SAFETY INFORMATION

WARNING: SERIOUS MENINGOCOCCAL INFECTIONS

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early.

  • Comply with the most current Advisory Committee on Immunization Practices (ACIP) recommendations for meningococcal vaccination in patients with complement deficiencies.
  • Immunize patients with meningococcal vaccines at least 2 weeks prior to administering the first dose of Soliris, unless the risks of delaying Soliris therapy outweigh the risk of developing a meningococcal infection [see Warnings and Precautions for additional guidance on the management of the risk of meningococcal infection].
  • Vaccination reduces, but does not eliminate, the risk of meningococcal infections. Monitor patients for early signs of meningococcal infections and evaluate immediately if infection is suspected.

Soliris is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS). Under the Soliris REMS, prescribers must enroll in the program. Enrollment in the Soliris REMS program and additional information are available by telephone: 1-888-SOLIRIS (1-888-765-4747) or at www.solirisrems.com.

CONTRAINDICATIONS

Soliris is contraindicated in:

  • Patients with unresolved serious Neisseria meningitidis infection
  • Patients who are not currently vaccinated against Neisseria meningitidis, unless the risks of delaying Soliris treatment outweigh the risks of developing a meningococcal infection

WARNINGS AND PRECAUTIONS

Serious Meningococcal Infections

Risk and Prevention

See Boxed WARNING for additional information on serious meningococcal infections.

Life-threatening and fatal meningococcal infections have occurred in patients treated with Soliris. The use of Soliris increases a patient's susceptibility to serious meningococcal infections (septicemia and/or meningitis).

Vaccinate for meningococcal disease according to the most current ACIP recommendations for patients with complement deficiencies. Revaccinate patients in accordance with ACIP recommendations, considering the duration of Soliris therapy.

Immunize patients without a history of meningococcal vaccination at least 2 weeks prior to receiving the first dose of Soliris. If urgent Soliris therapy is indicated in an unvaccinated patient, administer meningococcal vaccine(s) as soon as possible and provide patients with 2 weeks of antibacterial drug prophylaxis.

The benefits and risks of antibiotic prophylaxis for prevention of meningococcal infections in patients receiving Soliris have not been established.

Vaccination reduces, but does not eliminate, the risk of meningococcal infections.

Closely monitor patients for early signs and symptoms of meningococcal infection and evaluate patients immediately if an infection is suspected. Meningococcal infection may become rapidly life-threatening or fatal if not recognized and treated early. Discontinue Soliris in patients who are undergoing treatment for serious meningococcal infections.

REMS

Because of the risk of meningococcal infections, Soliris is available only through a restricted program under a REMS. Under the Soliris REMS, prescribers must enroll in the program.

Prescribers must counsel patients about the risk of meningococcal infection, provide the patients with the REMS educational materials, and ensure patients are vaccinated with meningococcal vaccine(s).

Other Infections

Serious infections with Neisseria species (other than N. meningitidis), including disseminated gonococcal infections, have been reported.

Soliris blocks terminal complement activation; therefore patients may have increased susceptibility to infections, especially with encapsulated bacteria. Additionally, Aspergillus infections have occurred in immunocompromised and neutropenic patients. Children treated with Soliris may be at increased risk of developing serious infections due to Streptococcus pneumoniae and Haemophilus influenzae type b (Hib). Administer vaccinations for the prevention of Streptococcus pneumoniae and Haemophilus influenzae type b (Hib) infections according to ACIP guidelines. Use caution when administering Soliris to patients with any systemic infection.

Monitoring Disease Manifestations After Soliris Discontinuation

Treatment Discontinuation for PNH

Monitor patients after discontinuing Soliris for at least 8 weeks to detect hemolysis.

Treatment Discontinuation for aHUS

After discontinuing Soliris, monitor patients with aHUS for signs and symptoms of thrombotic microangiopathy (TMA) complications for at least 12 weeks. In aHUS clinical trials, 18 patients (5 in the prospective studies) discontinued Soliris treatment. TMA complications occurred following a missed dose in 5 patients, and Soliris was reinitiated in 4 of these 5 patients.

Clinical signs and symptoms of TMA include changes in mental status, seizures, angina, dyspnea, or thrombosis. In addition, the following changes in laboratory parameters may identify a TMA complication: occurrence of 2, or repeated measurement of any one of the following: a decrease in platelet count by 25% or more compared to baseline or the peak platelet count during Soliris treatment; an increase in serum creatinine by 25% or more compared to baseline or nadir during Soliris treatment; or, an increase in serum LDH by 25% or more over baseline or nadir during Soliris treatment.

If TMA complications occur after Soliris discontinuation, consider reinstitution of Soliris treatment, plasma therapy [plasmapheresis, plasma exchange, or fresh frozen plasma infusion (PE/PI)], or appropriate organ-specific supportive measures.

Thrombosis Prevention and Management

The effect of withdrawal of anticoagulant therapy during Soliris treatment has not been established. Therefore, treatment with Soliris should not alter anticoagulant management.

Infusion Reactions

Administration of Soliris may result in infusion reactions, including anaphylaxis or other hypersensitivity reactions. In clinical trials, no patients experienced an infusion reaction that required discontinuation of Soliris. Interrupt Soliris infusion and institute appropriate supportive measures if signs of cardiovascular instability or respiratory compromise occur.

Adverse Reactions

The most frequently reported adverse reactions in the PNH randomized trial (≥10% overall and greater than placebo) are: headache, nasopharyngitis, back pain, and nausea.

The most frequently reported adverse reactions in aHUS single arm prospective trials (≥20%) are: headache, diarrhea, hypertension, upper respiratory infection, abdominal pain, vomiting, nasopharyngitis, anemia, cough, peripheral edema, nausea, urinary tract infections, pyrexia.

The most frequently reported adverse reaction in the gMG placebo-controlled clinical trial (≥10%) is: musculoskeletal pain.

The most frequently reported adverse reactions in the NMOSD placebo-controlled trial (≥10%) are: upper respiratory infection, nasopharyngitis, diarrhea, back pain, dizziness, influenza, arthralgia, pharyngitis, and contusion.

Please see accompanying full prescribing information for Soliris® , including BOXED WARNING regarding serious meningococcal infections.

IMPORTANT SAFETY INFORMATION FOR KANUMA® 

Indications and Usage

KANUMA® is indicated for the treatment of patients with a diagnosis of lysosomal acid lipase deficiency (LAL-D).  

WARNINGS AND PRECAUTIONS

Hypersensitivity Reactions Including Anaphylaxis

Hypersensitivity reactions, including anaphylaxis, have been reported in KANUMA® -treated patients. In clinical trials, 3 of 106 (3%) patients treated with KANUMA® experienced signs and symptoms consistent with anaphylaxis. These patients experienced reactions during infusion with signs and symptoms including chest discomfort, conjunctival injection, dyspnea, generalized and itchy rash, hyperemia, swelling of eyelids, rhinorrhea, severe respiratory distress, tachycardia, tachypnea, and urticaria. Anaphylaxis has occurred as early as the sixth infusion and as late as 1 year after treatment initiation.

In clinical trials, 21 of 106 (20%) KANUMA® -treated patients, including 9 of 14 (64%) infants and 12 of 92 (13%) pediatric patients, 4 years and older, and adults experienced signs and symptoms either consistent with or that may be related to a hypersensitivity reaction. Signs and symptoms of hypersensitivity reactions, occurring in two or more patients, included abdominal pain, agitation, fever, chills, diarrhea, eczema, edema, hypertension, irritability, laryngeal edema, nausea, pallor, pruritus, rash, and vomiting. The majority of reactions occurred during or within 4 hours of the completion of the infusion. Patients were not routinely pre-medicated prior to infusion of KANUMA® in these clinical trials.

Due to the potential for anaphylaxis, appropriate medical support should be readily available when KANUMA®  is administered.

Consider the risks and benefits of re-administering KANUMA® following a severe reaction. Monitor patients, with appropriate resuscitation measures available, if the decision is made to re-administer the product.

Hypersensitivity to Eggs or Egg Products

Patients with a known history of egg allergies were excluded from the clinical trials. Consider the risks and benefits of treatment with KANUMA®  in patients with known systemic hypersensitivity reactions to eggs or egg products.

ADVERSE REACTIONS

The most common adverse reactions are:

  • In Patients with Rapidly Progressive Disease Presenting within the First 6 Months of Life (>30%): diarrhea, vomiting, fever, rhinitis, anemia, cough, nasopharyngitis, and urticaria.
  • In Pediatric and Adult Patients (≥8%): headache, fever, oropharyngeal pain, nasopharyngitis, asthenia, constipation, and nausea.

Please see full prescribing information for Kanuma® .

IMPORTANT SAFETY INFORMATION FOR STRENSIQ® 

Indications and Usage

STRENSIQ®  is indicated for the treatment of patients with perinatal-, infantile- and juvenile-onset hypophosphatasia (HPP).

Warnings and Precautions

Hypersensitivity reactions, including anaphylaxis, have been reported in STRENSIQ® -treated patients. Signs and symptoms consistent with anaphylaxis included difficulty breathing, choking sensation, nausea, periorbital edema, and dizziness. These reactions have occurred within minutes after subcutaneous administration of STRENSIQ®  and can occur in patients on treatment for more than one year. Other hypersensitivity reactions have also been reported in STRENSIQ® -treated patients, including vomiting, fever, headache, flushing, irritability, chills, skin erythema, rash, pruritus and oral hypoesthesia.  If a severe hypersensitivity reaction occurs, discontinue STRENSIQ®  treatment and initiate appropriate medical treatment. Consider the risks and benefits of re-administering STRENSIQ®  to individual patients following a severe reaction. If the decision is made to re-administer the product, monitor patients for a reoccurrence of signs and symptoms of a severe hypersensitivity reaction. 

Localized lipodystrophy, including lipoatrophy and lipohypertrophy, has been reported at injection sites after several months in patients treated with STRENSIQ® . Advise patients to follow proper injection technique and to rotate injection sites.

Patients with HPP are at increased risk for developing ectopic calcifications. In clinical trials, 14 cases (14%) of ectopic calcification of the eye including the cornea and conjunctiva, and the kidneys (nephrocalcinosis) were reported. There was insufficient information to determine whether or not the reported events were consistent with the disease or due to STRENSIQ® . No visual changes or changes in renal function were reported.  Ophthalmology examinations and renal ultrasounds are recommended at baseline and periodically during treatment with STRENSIQ®  to monitor for signs and symptoms of ophthalmic and renal ectopic calcifications and for changes in vision or renal function.

Adverse Reactions

The most common adverse reactions (≥ 10%) are injection site reactions, lipodystrophy, ectopic calcifications and hypersensitivity reactions.

Please see full prescribing information for Strensiq® .

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