Another sparse month for EMA/CHMP new drug recommendations

At its June meeting, the European Medicines Agency’ Committee for Medicinal Products for Human Use (CHMP) issued recommendations on three medicines for approval, plus a negative opinion and some indications extensions.

The Committee recommended granting a marketing authorisation for Giapreza (angiotensin II), from USA-based La Jolla Pharmaceutical (Nasdaq: LJPC), for the treatment of refractory hypotension in adults with septic or other distributive shock. The benefit with Giapreza is its ability to increase blood pressure in patients with septic and distributive shock. The most common side effects are thromboembolic events, transient hypertension, tachycardia and peripheral ischemia.

Two informed consent applications received a positive opinion from the CHMP: Azacitidine Celgene (azacitidine), from US biotech Celgene (Nasdaq: CELG), for the treatment of myelodysplastic syndromes, chronic myelomonocytic leukemia and acute myeloid leukemia; and Lacosamide UCB (lacosamide), from Belgium’s UCB (Euronext Brussels: UCB), for the treatment of partial-onset seizures with or without secondary generalisation. An informed consent application makes use of data from the dossier of a previously authorized medicine, with the marketing authorization holder of that medicine giving consent for the use of their data in the application.