Opsynvi Approved to Treat Pulmonary Arterial Hypertension

On Mar. 22, 2024, Johnson & Johnson announced that the U.S. Food and Drug Administration (FDA) approved Opsynvi^® (macitentan/tadalafil) tablets. Combining an endothelin receptor antagonist (ERA) to lower the chance of disease progression and a phosphodiesterase 5 (PDE5) inhibitor to enhance the ability to exercise, it is taken once a day to treat pulmonary arterial hypertension (PAH). It can be used as first-line therapy or after previous treatment for adults who have World Health Organization (WHO) Group I and WHO Functional Class [FC] II-III PAH. Opsynvi has a boxed warning because taking it during pregnancy can damage the unborn baby. Women who take it must be registered with a risk evaluation and mitigation strategy (REMS) for Opsynvi before it can be prescribed for them. Johnson & Johnson has not announced launch and pricing plans. Full prescribing information is here.

At a Glance

• Brand (Generic) Name: Opsynvi (macitentan/tadalafil)
• Manufacturer: Johnson & Johnson
• Date Approved: March 22, 2024 (announced)
• Indication: for chronic treatment PAH, WHO Group I in adult patients of WHO functional class (FC) II-III
• Dosage Forms Available: oral tablets containing 10mg of macitentan and either 20mg or 40mg of tadalafil
• Launch Date: The launch date isn’t known at this time.
• Estimated Cost: Pricing information is not yet available.
• PAH is one of five kinds of high blood pressure that affects the lungs. Designated as Group I, it causes gradually worsening constriction and thickening of small arteries in the lungs, which eventually weakens the heart.
• With fewer than 1,000 new cases diagnosed annually, many patients are young and middle-aged women, especially those of African and Hispanic heritage.
• Macitentan blocks endothelin, a peptide that constricts blood vessels. Tadalafil helps to relax smooth muscles in blood vessels.
• After four months of treatment, the change in pulmonary vascular resistance, a measure of PAH severity, was about 30% better for patients taking Opsynvi than those taking only macitentan or only tadalafil in the pivotal clinical trial.
• A REMS is required for women who take Opsynvi, which has damaged developing fetuses in laboratory animals. Female patients must be tested for pregnancy before beginning it, each month while in treatment, and for at least one month after therapy stops.
• Other serious side effects may include liver damage, low blood pressure, and visual or hearing impairments.
• Several other drugs – including generic tadalafil tablets and Opsumit^® (macitentan) tablets – are FDA-approved for treating PAH.
• Merck’s sotatercept, a fusion protein based on the activin receptor type IIA (ActRIIA), is currently under FDA review for treating PAH. Administered once every three weeks as a subcutaneous (SC) injection, it is used in combination with a patient’s current treatment regimen. The FDA is expected to complete its review by tomorrow (03/26/2024).