2024-08-28 15:43:00
The European Commission (EC) has approved sotatercept, in combination with other therapies for pulmonary arterial hypertension (PAH), for the treatment of PAH in elderly patients in the functional class of the World Health Organization (Cf) II to III (WHO). to improve exercise capacity. . This was announced by MSD – known as Merck & Co. in the United States and Canada – in a note in which it is stated that sotatercept is the first and only activin signaling inhibitor therapy for PAH approved in all 27 member states of the EU, as well as in Iceland, Liechtenstein and Norway. The drug works by improving the balance between pro-proliferative and pro-proliferative signaling to regulate the proliferation of muscle cells under IAP. The European Commission’s approval of sotatercept is based on safety and efficacy results from the Phase 3 Stellar study.
“The approval of sotatercept by the EC – says Joerg Koglin, Senior Vice President and Head of General Medicine, Global Clinical Development, Merck Research Laboratories – represents an important event for patients: it is the first targeted therapy in ‘activin. We are proud to bring this innovative treatment to more patients and are committed to further researching the potential of sotatercept in areas where there are unmet needs in the management of PAH. ”
PAH is a rare, progressive, high-risk, fatal circulatory disorder characterized by narrowing of the small pulmonary arteries and elevated blood pressure in the pulmonary circulation. This places significant strain on the heart, resulting in limited physical activity, heart failure and reduced life expectancy. The 5-year mortality rate is approximately 43%, based on data from the Exposure registry. It is “a crippling disease – explains Marc Humbert, professor of medicine and director of the Reference Center for Pulmonary Hypertension at Paris-Saclay University – Patients suffer from symptoms that can reduce their daily activities”. For this reason “new therapeutic options continue to be important. Based on the Stellar Phase 3 study, the addition of sotatercept to PAH therapy improved exercise capacity, reduced the risk of death or adverse clinical events, and improved performance compared to standard PAH therapy alone. These results – adds Humbert – are important and strengthen the idea that sotatercept, in combination with other therapies for PAH, should be considered the new standard of care for the treatment of elderly patients in functional class II and III” .
In detail, the Stellar study compared sotatercept (n = 163) with placebo (n = 160) both in combination with medical therapy in elderly patients with PAH (WHO Group 1, Cf II or III). The primary endpoint was change from baseline to week 24 in six-minute walking distance. Treatment with sotatercept resulted in a statistically significant and clinically significant improvement in six-minute walking distance of 40.8 meters compared to placebo. The treatment also greatly improved important secondary outcomes, including a reduction in the risk of death or hospitalization.
The treatment has received the certification of a Representative Medicine (Prime) and an orphan drug for the treatment of PAH from the EMA. On March 26, 2024, sotatercept was approved by the US FDA in the United States for adults with IAP, WHO Group 1, to increase exercise capacity, improve WHO functional class (Cf), and reduce the risk of events worse hospital.
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