Macitentan/Tadalafil

The European Commission has approved Johnson and Johnson’s Yuvanci for pulmonary arterial hypertension, offering the first single-pill treatment option to European patients. Credit: andreswd via Getty Images. The European Commission (EC) has approved Johnson and Johnson’s Yuvanci (macitentan + tadalafil) for the treatment of pulmonary arterial hypertension (PAH). The approval marks Yuvanci as the only single-tablet combination therapy available for patients with PAH. PAH is a rare, progressive disorder in which patients have high blood pressure in the pulmonary arteries for no apparent reason. Current treatment for PAH involves first-line dual combination therapy with macitentan and tadalafil for patients without cardiopulmonary comorbidities. This currently consists of a multi-pill regimen. “This can deeply impact their [PAH patients’] daily lives as they might struggle to maintain adherence to their treatment regimen,” said Dr. Tamara Werner-Kiechle, the Europe, Middle East, and Africa (EMEA) therapeutic area lead for neuroscience and cardiopulmonary drugs at Johnson & Johnson Innovative Medicine in a 30 September press release. Johnson and Johnson has developed the Yuvanci as a substitution therapy for the long-term treatment of PAH in adults of the World Health Organization’s (WHO) Functional Class (FC) II to III. This includes patients with PAH that causes a slight limitation in physical activity, yet they are still comfortable at rest, and “patients with marked limitations to physical activity”, as per WHO. Patients will need to have already been treated with a two-pill combination of macitentan and tadalafil to be eligible for Yuvanci. Johnson and Johnson currently markets macitenan monotherapy under the brand name Opsumit, whilst Eli Lilly sells tadalafil as Cialis for PAH. The approval is based on data from the Phase III A DUE study (NCT03904693) , which also led to a positive recommendation for Yuvanci’s approval by the European Medicines Agency’s (EMA) Committee for Human Medicinal Products in July. The pharmaceutical giant presented data from the Phase III A DUE clinical study at the American College of Cardiology’s 72nd Annual Scientific Session. In the double-blind study, Yuvanci-treated patients showed significant improvements in the co-primary endpoints of pulmonary vascular resistance (PVR) and pulmonary haemodynamic improvement. Patients who took the combination therapy demonstrated a 44% decrease in PVR compared to a 22% decrease in the Adcirca monotherapy group. See Also: Almac Group North American Headquarters Expansion, Pennsylvania, USA LOTTE BIOLOGICS’ East Syracuse Pharmaceutical Manufacturing Facility, US Opsumit is an endothelin receptor antagonist that treats PAH by inhibiting pathways related to vasoconstriction, fibrosis and proliferation. Meanwhile, Cialis is a phosphodiesterase type-5 inhibitor that treats the disorder by increasing cGMP, leading to a relaxation of the pulmonary vascular smooth muscle cell and vasodilation of the pulmonary vascular bed. Johnson and Johnson submitted a new drug application to the US Food and Drug Administration (FDA) for Yuvanci in May 2023, receiving an approval for its submission in March 2024.

MSD’s Winrevair has been approved to treat pulmonary arterial hypertension (PAH), a disorder which is caused by high blood pressure in the lungs. Credits: MMD Creative/Shutterstock.com The European Commission (EC) has granted approval to Merck & Co’s (MSD) Winrevair (sotatercept) to be used as a combination therapy for the treatment of adults with functional class II or III pulmonary arterial hypertension (PAH). The approval was awarded based on data from STELLAR, a Phase III study (NCT04576988) that evaluated 323 adult participants with functional class II or III PAH, as determined by the World Health Organization (WHO), as per the 26 August press announcement, The European approval for the subcutaneously administered therapy follows one from the US Food and Drug Administration (FDA) in March 2024 for the same group of PAH patients. According to GlobalData’s consensus forecasts, Winrevair is expected to generate total sales of $6.3bn in 2030. GlobalData is the parent company of Pharmaceutical Technology . Notably, a day before the approval of Winrevair, the FDA granted approval to Johnson & Johnson ’s (J&J) Opsynvi (macitentan + tadalafil). Opsynvi is approved to treat adult patients with WHO Group 1 and functional classes II and III PAH. According to study results published in the New England Journal of Medicine, Winrevair demonstrated a median change in 6-minute walk distance (6MWD) from baseline of 34.4m, which was superior to the 1.0m with placebo at 24 weeks, the study’s primary efficacy endpoint. While the number of reported adverse events was similar in the treatment and placebo groups (138 vs. 140), participants receiving Winrevair experienced more frequent cases of epistaxis, dizziness, telangiectasia, increased hemoglobin levels, thrombocytopenia, and increased blood pressure. See Also: Singapore approves mpox vaccine as it adds border infection checks EC approves Roche’s monoclonal antibody PiaSky to treat PNH Winrevair is a first-in-class activin signaling inhibitor designed to increase exercise capacity by binding to several TGF beta superfamily ligands and blocking their signals that contribute to the progression of PAH. As the first approved PAH therapy targeting the activin signaling pathway, the EC approval of Winrevair is an “important step for patients,” said Dr. Joerg Koglin, MSD senior VP and head of general medicine, global clinical development at Merck Research Laboratories. MSD is committed to further investigation of Winrevair in areas of “unmet needs in the management of PAH,” Koglin added. PAH is a rare, blood vessel disorder characterised by the narrowing of the small blood vessels in an individual’s lungs, which results in high blood pressure (hypertension) in the pulmonary artery. MSD is one of several companies developing treatments for PAH. In 2023, GlobalData tracked 129 drugs in development for PAH, nine of which were under development by institutes and universities.