FDA OKs Sotatercept, Merck's Pulmonary Arterial Hypertension Drug

The FDA has approved sotatercept, a new treatment for pulmonary arterial hypertension.

Merck is selling the drug under the brand name Winrevair.

Merck is pricing the drug at $14,000 per vial, before any rebates or discounts.

Merck says that approximately two-thirds of patients will need to be treated with a vial every three weeks. At that frequency, the annual cost would add to up approximately $240,000.

Pulmonary arterial hypertension (PAH) is a characterized by high blood pressure in the arteries of the lungs. PAH usually affects women between the ages of 30 and 60, according to the National Organization of Rare Disorders.

Today’s approval came just a day after the FDA approved Opsynvi for PAH. A Johnson & Johnson product, Opsynvi combines macitanten and tadalafil, which are commonly prescribed to treat PAH. Tadalafil is also an erectile dysfunction drug that is sold under the brand name Cialis.

Merck said in a press release today that Winrevair would be available from select specialty pharmacies by the end of next month,

The drug is administered by subcutaneous (under the skin) injection.The Merck press release says it can be administered by patients or caregivers with guidance, training and follow-up from a healthcare provider.

This is a developing story.