STRENSIQ is an innovative enzyme replacement therapy approved for the treatment of patients with perinatal/infantile- and juvenile-onset hypophosphatasia (HPP).1 STRENSIQ is approved in the United States, European Union, Japan, Canada, and other countries.
STRENSIQ is the first therapy indicated in patients with perinatal/infantile- and juvenile-onset HPP to treat the underlying cause of HPP—deficient TNSALP. By replacing the deficient ALP, STRENSIQ reduces the elevated enzyme substrate levels and improves bone mineralization. STRENSIQ is administered via subcutaneous injection (injection under the skin).1
The safety and efficacy of STRENSIQ were evaluated in 4 prospective, open-label clinical trials and supporting extension trials comprising 112 patients with HPP (ages 1 day to 66.5 years) who received treatment with STRENSIQ for up to 7.5 years.2-7 At 48 weeks, estimated overall survival was 94% for STRENSIQ-treated patients compared with 42% for untreated historical control patients (hazard ratio [95% CI], 0.174 [0.072, 0.421]).2-5
Patients treated with STRENSIQ also demonstrated radiographic improvement. In patients with perinatal/infantile-onset HPP, 78% (63/81) of patients treated with STRENSIQ were rated as responders on the 7-point Radiographic Global Impression of Change (RGI-C) scale at last assessment (mean time from baseline to last assessment was 35.7 months; range was 2.5 months to 89.4 months).2-4,6 In patients with juvenile-onset HPP, 100% (8/8) of STRENSIQ-treated patients were rated as RGI-C responders by 54 months of treatment compared with 6% (2/32) of untreated historical control patients (mean duration between baseline and last assessment for control patients was 56 months; range was 8 to 95 months).6
The most common adverse reactions (≥10%) are: injection site reactions, lipodystrophy, ectopic calcifications, and hypersensitivity reactions.1