The Committee for Medicinal Products for Human Use (CHMP) has recommended granting a marketing authorisation for Eperzan (albiglutide), for the treatment of type 2 diabetes.
CHMP gave a positive recommendation for Adempas (riociguat) for the treatment of chronic thromboembolic pulmonary hypertension and pulmonary arterial hypertension. Adempas has an orphan designation.
The Committee recommended the granting of a marketing authorisation for Latuda (lurasidone) for the treatment of schizophrenia and gave a positive recommendation for Bemfola (follitropin alfa), a new biosimilar medicine for the treatment of infertility.
Two generic medicines were also recommended for approval by the CHMP: Rivastigmine 3M Health Care Ltd for the treatment of Alzheimer’s dementia and Zoledronic acid Teva Generics for the treatment of osteoporosis and Paget’s disease of the bone.
Finally the body also recommended the approval of Hemoprostol(misoprostol), indicated for the treatment of post-partum haemorrhage due to uterine atony in situations where intravenous oxytocin is not available. Hemoprostol will be intended exclusively for markets outside the European Union.