Regulators squeezed in two final approvals before the calendar change with the UK approval of Merck’s Winrevair and the FDA’s greenlight for an injectable formulation of BMS’s cancer blockbuster.
Regulators stayed busy over the holidays, squeezing in a few more drug approvals just before the midnight ball drop. Merck’s high-priced acquisition finally got the nod in the UK for a rare lung condition, and the FDA greenlit an injectable version of BMS’ blockbuster cancer drug Opdivo.
On Tuesday, the UK’s Medicines and Healthcare products Regulatory Agency approved Winrevair (sotatercept) for pulmonary arterial hypertension (PAH), a rare disease that causes high blood pressure in the lungs and can eventually lead to organ failure. Merck scored FDA approval for Winrevair in March 2024 and in the E.U. in August.
The drug was believed to be a “game changer” for a disease with a very high mortality rate, Jeremy Feldman, director of the pulmonary hypertension program and medical director for high-risk care at Summit Heath, told BioSpace at the time. The new therapeutic class targets an underlying cause of PAH, improving the balance between pro- and anti-proliferative signaling.
In 2021, Merck paid $11.5 billion to acquire Acceleron Pharma, with sotatercept, a first-in-class activin signaling inhibitor therapy for PAH, as the lead asset. The drug is expected to be a potential blockbuster for Merck, with the PAH market projected to reach a value of $12.2 billion by 2032. As of Merck’s third quarter earnings report, the drug had already posted sales of $219 million since its March launch and is expected to top $1.5 billion in 2025.
Meanwhile, on the other side of the pond, BMS scored a late December win when the FDA approved its bestselling cancer drug Opdivo in an injectable version on Monday. The anti-PD-1 therapy is approved in a number of oncological indications including melanomas, non-small cell lung cancer, esophageal cancers and more. It was first approved as a 30-minute intravenous infusion given every two or four weeks.
Dubbed Opdivo Qvantig, BMS worked with Halozyme Therapeutics to bring the intravenous infusion to subcutaneous formulation. The new injectable version is expected to enhance patient convenience and may help protect BMS sales erosion as the IV formulation approaches the dreaded patent cliff in 2028. It’s approved for all previously approved adult, solid tumor indications as a monotherapy or in combination with chemotherapy.
In the first nine months of 2024, Opdivo brought in $6.8 billion in sales as BMS’ top-selling cancer product. This year, BMS is undergoing a “strategic productivity initiative” that is expected to generate around $1.5 billion in cost savings for the pharma giant.
