FDA Approves Alexion Pharma’s Strensiq for Bone Disorder

The FDA Oct. 23 approved Strensiq (asfotase alfa) as the first treatment for perinatal, infantile and juvenile-onset hypophosphatasia (HPP).

HPP is a rare, genetic, progressive, metabolic disease in which patients experience devastating effects on multiple systems of the body, leading to severe disability and life-threatening complications, the agency said. It is characterized by defective bone mineralization that can lead to rickets and softening of the bones that results in skeletal abnormalities. It also can cause complications such as profound muscle weakness with loss of mobility, seizures, pain, respiratory failure and premature death.

Strensiq is administered via injection three or six ...