FDA approves Alexion’s metabolic bone disorder drug
Oct 23 (Reuters) – The U.S. Food and Drug Administration on Friday approved Alexion Pharmaceuticals Inc’s Strensiq, a treatment for a rare kind of metabolic bone disorder.
The approval is the first in the United States for a treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP). (1.usa.gov/1W9KuRH)
HPP is a genetic and potentially fatal disorder that weakens bones, leading to skeletal abnormalities, with the most severe forms tending to occur before birth and in early infancy.
The debilitating disorder affects fewer than 200,000 patients in the United States, the FDA said.
Strensiq, to be administered by injection three or six times a week, was approved by Japan health regulators in July.
Alexion said it expects the drug to be commercially available in the United States on Oct. 27.
Alexion’s shares were up about 2.7 percent at $175.70 in after-market trade. The Cheshire, Connecticut-based company’s shares closed at $171.16 on the Nasdaq on Friday.
(Reporting by Samantha Kareen Nair in Bengaluru; Editing by Savio D’Souza)
Source: Reuters Health