………. catching up on FDA approvals
The FDA recently approved a new subcutaneous therapy, Winrevair (sotatercept-csrk) from Merck & Co. Winrevair is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH) a rare, progressive disease. The treatment seeks to increase exercise capacity, improve WHO functional class (FC) and reduce the risk of clinical worsening events.
Winrevair, a biologic, is the first FDA-approved activin signaling inhibitor therapy for PAH. It represents a new class of therapy that works by improving the balance between pro- and anti-proliferative signaling to regulate vascular cell proliferation underlying PAH.
Winrevair is given once every three weeks by subcutaneous injection and “may be administered by appropriate patients or caregivers with guidance, training and follow-up from a healthcare provider.”
Winrevair will carry a list price of $14,000 per vial. According to data from the company’s trial, most patients will use a single vial every three weeks, which would translate to $238,000 per year.
Merck announced that the therapy will be distributed through specialty pharmacy but did not specify any particular providers(s).
CLICK HERE for prescribing information
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