Approval of Merck’s treatment for individuals with high blood pressure brought on by pulmonary artery constriction was approved by the U.S. Food and Drug Administration, giving the multinational pharmaceutical company access to yet another potentially game-changing medication.
Merck’s stock rose more than 4% during extended trading.
About 40,000 Americans suffer with pulmonary arterial hypertension (PAH), which can be treated with the medication known as Winrevair.
“We look forward to making a significant difference for these patients that are left with a disease where the five year mortality is 43%,” Jannie Oosthuizen, president of Merck’s U.S. Human Health business, said.
According to Oosthuizen, Winrevair will have a list price of $14,000 per vial. The majority of patients, based on data from the company’s experiment, will need one vial every three weeks, or $238,000 annually.
By the end of April, the pharmaceutical company hopes to get the medication on the market.
As part of their $11.5 billion acquisition of Acceleron Pharma in 2021, Merck acquired the rights to Winrevair. As part of its plan to combat a potential blow to sales of its top-selling cancer treatment, Keytruda, from biosimilars later in the decade, the company has been bolstering its line of cardiovascular medications.
Sotatercept, also known as winrevair, is the first medication in its class to receive FDA clearance. These medications work by targeting a protein called activin, which raises levels of a follicle-stimulating hormone linked to the illness.
The aetiology of PAH is a narrowing of the arteries in the lungs, which results in elevated blood pressure and symptoms include dizziness, shortness of breath, and chest pain.
In addition to making the heart work harder to pump blood, hypertension can lead to heart failure.
“We see sotatercept having a strong initial launch and quickly becoming part of the standard of care for eligible PAH patients,” J.P. Morgan analyst Chris Schott wrote in a note.
By 2030, Schott projects that revenues of the therapy will peak at roughly $5 billion.
Merck’s medication was approved after a 24-week late-stage trial including 323 PAH patients.
Compared to the placebo group, participants receiving the medication in the trial shown a significant improvement in their ability to exercise, walking 40.8 metres farther in 6 minutes.
(Adapted from CNBC.com)









