US FDA to Review Ipsen’s Rare Bone Growth Disease Therapy

The US Food and Drug Administration (FDA) has set a date to decide on Ipsen’s new drug application for its drug candidate palovarotene in the treatment of fibrodysplasia ossificans progressive (FOP), a rare disorder where extra-skeletal tissues like muscles and tendons are converted into bone tissue. This would be the first therapy for the disabling, progressive condition.

According to Phil Taylor, “The drug is to reduce the formation of these extra-skeletal bone deposits, striking at the mechanism underlying the disease. At the moment, the only therapy available to patients with FOP are drugs to treat symptoms including pain, and the prospect of a disease-modifying therapy has earned palovarotene a breakthrough designation from the FDA.”

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(Source: PharmaPhorum, March 17^th, 2023)