HQ Team
September 28, 2023: Merck’s Biological Licence Application for a pulmonary arterial hypertension drug has been accepted for a priority review by the FDA.
The investigational drug, sotatercept, is used in adult patients, and the USFDA has set a target action date of March 26, 2024, according to a Merck statement.
For a priority review, a drug must address a serious condition. It must demonstrate, through clinical trial data or other scientifically valid information, the potential to provide a significant improvement in safety or effectiveness over existing treatments.
Pulmonary arterial hypertension is a rare, progressive and ultimately life-threatening disease characterised by the narrowing of blood vessels in the lungs, causing significant strain on the heart.
Approximately 40,000 people in the US are living with the disease, which progresses rapidly. The five-year mortality rate for patients with the disease is about 43%.
Six-minute walk distance
The application for sotatercept was based on data from a late-stage trial, in which the drug, on top of background therapy, demonstrated a “statistically significant and clinically meaningful improvement in 6-minute walk distance.”
It also yielded positive results on eight of nine secondary outcome measures.
“Despite advances in the treatment of PAH over the last two decades, there is still a significant need to improve outcomes for patients,” said Dr. Joerg Koglin, senior vice president, of global clinical development, at Merck Research Laboratories.
In pre-clinical models, sotatercept had been shown to modulate vascular cell proliferation, reversing vascular and right ventricle remodelling, according to the statement.
Sotatercept was granted Breakthrough Therapy Designation and Orphan Drug designation by the USFDA, as well as Priority Medicines designation and Orphan Drug designation by the European Medicines Agency.
Merck acquired exclusive rights to sotatercept in the pulmonary hypertension field through the acquisition of Acceleron Pharma Inc. Sotatercept is the subject of a licensing agreement with Bristol Myers Squibb.
