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FDA approved Winrevair for Pulmonary Arterial Hypertension (PAH) in AdultsFDA approved a new treatment for a serious lung condition called pulmonary arterial hypertension

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Key Takeaway
Consider Winrevair for adults with PAH; monitor hemoglobin and platelets closely due to required dosage modifications.

The FDA has approved Winrevair (sotatercept-csrk) for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1). The approval provides a new therapeutic option for a progressive and life-limiting condition. The drug is indicated to improve exercise capacity and WHO functional class, and to reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation, and death. Winrevair is administered as a subcutaneous injection every three weeks, with dosing based on patient weight. The label includes specific monitoring requirements for hemoglobin and platelet counts before and during treatment, with dosage modifications required for significant increases in hemoglobin or decreases in platelets. This approval introduces a new class of therapy, an activin signaling inhibitor, into the PAH treatment landscape.

Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Mechanism of Action

Winrevair is an activin signaling inhibitor.

Indication & Patient Population

WINREVAIR is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death.

Dosing & Administration

The recommended starting dose is 0.3 mg/kg by subcutaneous injection. The recommended target dose is 0.7 mg/kg every 3 weeks by subcutaneous injection. Dosage modifications due to increased hemoglobin (Hgb) and decreased platelets may be necessary. Check Hgb and platelets before each dose for the first 5 doses, or longer if values are unstable, and monitor periodically thereafter. Do not initiate treatment if platelet count is <50,000/mm3 (<50 x 10^9/L). Injection volume is calculated based on patient weight and the concentration of 50 mg/mL. The volume should be rounded to the nearest 0.1 mL. Specific kits (45 mg, 60 mg, 90 mg, 120 mg) are selected based on the calculated injection volume for the target dose. If a dose is missed, administer as soon as possible. If missed by more than 3 days, adjust the schedule to maintain 3-week intervals. For treatment delays lasting >9 weeks, restart at 0.3 mg/kg. Delay treatment for at least 3 weeks if: Hgb increases >2.0 g/dL from the previous dose and is above ULN; Hgb increases >4.0 g/dL from baseline; Hgb increases >2.0 g/dL above ULN; or platelet count decreases to <50,000/mm3.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

The U.S. Food and Drug Administration (FDA) has approved a new medicine called Winrevair. It is a treatment for adults with a serious condition called pulmonary arterial hypertension, or PAH. In PAH, high blood pressure develops in the arteries of the lungs, making the heart work harder and causing shortness of breath and fatigue. Winrevair is given as an injection under the skin every three weeks.

This approval is significant because it introduces a new type of medicine, called an activin signaling inhibitor, for treating PAH. In clinical studies, the drug was shown to help patients exercise longer, improve their functional class (a measure of how the disease affects daily life), and reduce the risk of serious events like hospitalization or the need for a lung transplant.

It's important to know that this is a prescription medicine with specific monitoring requirements. Doctors will need to check a patient's blood counts regularly before and during treatment, as the dose may need to be adjusted based on those results. This is a standard part of managing treatment with this drug.

This new approval offers hope as another tool for managing PAH. However, it is not a cure. Anyone interested in this new treatment should have a calm and open conversation with their healthcare provider. Only a doctor who knows a patient's full medical history can determine if Winrevair is a suitable option for their individual care plan.

What this means for you:
A new treatment option is now available, but patients should discuss it with their doctor.

Study Details

Study typeFda approval
PublishedMar 2024
View Original Abstract ↓
1 INDICATIONS AND USAGE WINREVAIR™ is indicated for the treatment of adults with pulmonary arterial hypertension (PAH, Group 1 pulmonary hypertension) to improve exercise capacity and World Health Organization (WHO) functional class (FC), and reduce the risk of clinical worsening events including hospitalization for PAH, lung transplantation and death [see Clinical Studies (14.1) ] . WINREVAIR is an activin signaling inhibitor indicated for the treatment of adults with pulmonary arterial hypertension (PAH, WHO Group 1 pulmonary hypertension) to improve exercise capacity and WHO functional class (FC), and reduce the risk of clinical worsening events, including hospitalization for PAH, lung transplantation and death. ( 1 )
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