FDA approves Merck’s WINREVAIR for pulmonary arterial hypertension

27 Mar 2024
www.pharmaceutical-technology.com
Phase 3Drug ApprovalFast TrackClinical ResultBreakthrough Therapy
FDA approves Merck’s WINREVAIR for pulmonary arterial hypertension
Preview
Source: Pharmaceutical Technology
MSD’s WINREVAIR is intended to enhance patient exercise capacity and reduce PAH linked risks. Credit: Merck & Co., Inc. / Business Wire.
The US Food and Drug Administration (FDA) has granted approval to Merck & Co (MSD)’s sotatercept-csrk, known by the brand name WINREVAIR, for the treatment of adults with pulmonary arterial hypertension (PAH).
It is the first FDA-approved activin-signalling inhibitor therapy for PAH.
PAH is a rare progressive and life-threatening disease in which blood vessels in the lungs narrow and thicken, leading to a huge strain on the heart.
The treatment is indicated for use in PAH patients to improve exercise capacity, enhance WHO functional class and decrease the likelihood of worsening clinical events.
The therapy, which had already received breakthrough therapy designation from the FDA, works by re-instating the balance between pro and anti-proliferative signalling to regulate the vascular cell proliferation linked to PAH.
See Also:
J&J’s nipocalimab gains FDA fast track status for FNAIT risk reduction
FDA approves Merck’s WINREVAIR for pulmonary arterial hypertension
Preview
Source: Pharmaceutical Technology
Takeda’s ADZYNMA gains Japanese approval for cTTP treatment
FDA approves Merck’s WINREVAIR for pulmonary arterial hypertension
Preview
Source: Pharmaceutical Technology
WINREVAIR is administered as a subcutaneous injection every three weeks.
The latest approval is based on results from the STELLAR trial, a global, double-blind, placebo-controlled, multicentre, parallel-group Phase III study.
It involved 323 adult patients and examined the effects of WINREVAIR compared to placebo, both given along with standard background therapies.
There was a significant 41m improvement in the six-minute walk distance from the baseline at week 24 when WINREVAIR was added to background therapy.
The treatment also substantially improved several secondary outcome measures, notably reducing morality or PAH clinical worsening event risks by 84% compared to background therapy alone.
The company will make WINREVAIR available through select speciality pharmacies in the US by the end of next month.
Merck Research Laboratories global clinical development senior vice-president, head and chief medical officer Dr Eliav Barr stated: “PAH remains a debilitating disease with high morbidity and mortality.
“This approval of WINREVAIR is an important milestone and a testament to our science-led strategy and focus on the development of innovations that can help people affected by rare diseases like PAH.”
Earlier this month, MSD completed the acquisition of Harpoon Therapeutics to bolster its oncology pipeline.
For more details,please visit the original website
The content of the article does not represent any opinions of Synapse and its affiliated companies. If there is any copyright infringement or error, please contact us, and we will deal with it within 24 hours.
Organizations
Indications
Targets
-
Drugs
Get started for free today!
Accelerate Strategic R&D decision making with Synapse, PatSnap’s AI-powered Connected Innovation Intelligence Platform Built for Life Sciences Professionals.
Start your data trial now!
Synapse data is also accessible to external entities via APIs or data packages. Leverages most recent intelligence information, enabling fullest potential.