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Alexion Pharma's Strensiq cleared in the EU for ultra-rare metabolic disease

Sep. 01, 2015 6:39 AM ETAlexion Pharmaceuticals, Inc. (ALXN) StockALXNBy: Douglas W. House, SA News Editor
  • The European Commission approves Alexion Pharmaceuticals' (NASDAQ:ALXN) Strensiq (asfotase alfa) for long term enzyme replacement therapy in patients with pediatric-onset hypophosphatasia (HPP) to treat bone manifestations of the disease. Strensiq is the first therapy cleared in the EU to treat HPP.
  • The company expects to launch Strensiq in Germany in October. Negotiations over reimbursement are in process in each of the major European countries.
  • HPP is an inherited disorder that affects multiple systems of the body. It is characterized by defective bone mineralization that can lead to deformity of bones and other skeletal abnormalities, in addition to systemic complications like profound muscle weakness, seizures, pain and respiratory failure leading to premature death in infants. It affects ~1 in 100K newborns.
  • Previously: Europe's CHMP adopts positive opinion supporting approval for two Alexion enzyme replacement therapies (June 26)

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