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Strensiq Approval History

  • FDA approved: Yes (First approved October 23rd, 2015)
  • Brand name: Strensiq
  • Generic name: asfotase alfa
  • Dosage form: Injection
  • Company: Alexion Pharmaceuticals, Inc.
  • Treatment for: Hypophosphatasia

Strensiq (asfotase alfa) is a tissue nonspecific alkaline phosphatase enzyme replacement therapy indicated for the treatment of patients with perinatal, infantile and juvenile-onset hypophosphatasia (HPP).

Development History and FDA Approval Process for Strensiq

DateArticle
Oct 23, 2015Approval FDA Approves Strensiq (asfotase alfa) for Perinatal, Infantile and Juvenile-Onset Hypophosphatasia
Dec 30, 2014Alexion Completes Rolling BLA Submission to FDA for Asfotase Alfa for Hypophosphatasia
Mar 29, 2012Asfotase Alfa Significantly Decreased TNSALP Substrates and Improved 6-Minute Walk Test Results in Adolescents and Adults with Hypophosphatasia (HPP)
Mar  7, 2012New England Journal of Medicine Publishes Data from Phase 2 Study of Asfotase Alfa in Life-Threatening Hypophosphatasia

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