EMA/CHMP January meeting highlights

There were a number of positive, and negative, opinions issued on January 24, following the monthly meeting of the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP; see also separate stories for GlaxoSmithKline and Novartis).

The Committee gave a positive recommendation for German drug major Bayer’s (BAYN: DE) Adempas (riociguat) for the treatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. Adempas has an orphan designation. The CHPP said the key benefits of the drug were "its ability to provide significant improvement in exercise capacity and pulmonary hemodynamics in two specific conditions known as chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension."

The Committee recommended the granting of a marketing authorization for Latuda (lurasidone), a treatment for schizophrenia from Japan’s largest drugmaker Takeda (TYP: 5402), which licenses European rights to the product from Dainippon Sumitomo Pharmaceuticals (TYO: 4506).