Canadian approval for Alexion's Strensiq

Medicines regulatory agency Health Canada has approved US drugmaker Alexion Pharmaceuticals’ (Nasdaq: ALXN) Strensiq (asfotase alfa) as enzyme replacement therapy for patients with confirmed diagnosis of pediatric-onset hypophosphatasia (HPP).

Strensiq, Alexion’s lead product candidate, is the first approved treatment for HPP, an ultra-rare, genetic, metabolic disease in which patients experience devastating, progressive effects on multiple organs of the body, leading to debilitating morbidities or pre-mature mortality.

"Strensiq is critical and pivotal for the treatment of patients with HPP who to date have not had an effective therapy. HPP is a rare and extremely debilitating disease.  It has a very high mortality rate in the most severe paediatric cases," said Cheryl Rockman-Greenberg, Distinguished Professor, Department of Pediatrics and Child Health, University Of Manitoba and Clinician Scientist in the Children's Hospital Research Institute of Manitoba, and lead Canadian investigator in the HPP trials.