At Alexion, we commit ourselves every day to delivering on our mission of serving people living with rare diseases. This is especially important during a global health crisis like the current COVID-19 pandemic. We remain focused on continuing to serve the patients who rely on us, as well as protecting the health and safety of our employees and the communities in which we live and work.
Commitment to Patients
The resilience of patients and their families is our inspiration, and the safety of those receiving our medicines and participating in our clinical trials remains paramount. Alexion's goal is always to manage a robust supply chain that delivers medicines that are secure, sterile and meet our rigorous quality standards. In addition, due to the life-saving nature of our medicines, we strive to maintain sufficient inventory levels to ensure their supply to the patients who rely on them. We have taken proactive measures to mitigate the risk of potential interruptions in supply, and we are continuing to actively monitor this dynamic and rapidly evolving situation worldwide.
On January 13, 2021, Alexion announced the decision to pause further enrollment in the global Phase 3 study of ULTOMIRIS® (ravulizumab-cwvz) in adults with severe COVID-19 requiring mechanical ventilation. This decision is based on the recommendation of an independent data monitoring committee (IDMC), following their review of data from a pre-specified interim analysis.
Alexion announced plans to initiate a global Phase 3 study to investigate ULTOMIRIS® (ravulizumab-cwvz) in a subset of adults with COVID-19 – those who are hospitalized with severe pneumonia or acute respiratory distress syndrome (ARDS).
Alexion is committed to assisting communities and medical systems in their efforts to address the public health crisis caused by the COVID-19 pandemic and is taking a holistic approach to supporting our global communities across a range of areas of need.
In early February, in response to the government’s outreach, Alexion reached out to the U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA) office, the Department of Defense (DoD) and others within government to discuss the potential use of SOLIRIS® (eculizumab) in patients with COVID-19.
Alexion is committed to doing our part to protect our own safety and the safety of those around us by being smart in our actions and minimizing any potential interactions that could contribute to the spread of the virus and place additional burden on our healthcare systems. The patients and families we serve, and their care teams, are at the front of our minds as we work to redefine what it means to effectively support them through increased virtual means in this dynamic and challenging environment.
Alexion's approach to responding to COVID-19 reflects the following priorities:
- Protecting patient and customer safety and medicine supply continuity;
- Ensuring safety and a sense of security for people who work at Alexion;
- Safeguarding our manufacturing, distribution and research facilities;
- Maintaining the integrity of our clinical trials and commitment to data quality;
- Responsibly supporting our community and local healthcare systems; and
- Remaining nimble and responsive to the ever-changing situation while always remaining true to our core values.
Patients Taking Alexion Medicines
We understand that you may have questions about COVID-19 and your medicine. If you are taking an Alexion medicine, please first speak with your doctor about any questions you have. If you have additional questions, and are in the U.S., please call OneSource at 1-888-765-4747. If you live outside the U.S., local contact information by country can be found here.
If you are a healthcare provider with questions about COVID-19 and Alexion medicines, please contact Alexion’s Medical Information team at MedInfo@alexion.com (global) or 1-888-765-4747 (U.S.).
Clinical Trial Participants
If you are an investigator with questions about COVID-19, please contact your:
- Clinical Research Associate (CRA) or the study Medical Monitor for Alexion-sponsored clinical trials
- Medical Science Liaison or Country Medical Affairs Manager for Investigator Sponsored Research funded by Alexion
If you are a patient enrolled in an Alexion-sponsored clinical trial or Investigator Sponsored Research funded by Alexion with questions about COVID-19, please contact your trial physician.
Emergency Treatment for COVID-19
In recognition of the urgent needs of some patients and in order to streamline the emergency access process, Alexion has opened emergency Expanded Access Programs (EAPs) in the U.S. and France for severe COVID-19 pneumonia. More information on our emergency EAPS for COVID-19 can be found here.
If anything, living with PNH has made me appreciate my time even more, and given me more drive to get back to doing what I love to do.”JOE LIVING WITH PNH