Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2023 (new)

Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 19-22 June 2023 News 23/06/2023 Two new medicines recommended for approval EMA’s human medicines committee (CHMP) recommended two medicines for approval at its June 2023 meeting. The committee recommended granting a marketing authorisation for Aquipta (atogepant monohydrate), intended for the prophylaxis of migraine in adults who have at least four migraine days per month. It is estimated that approximately 15% of the EU population suffers from migraine, a type of headache characterised by recurrent attacks of moderate to severe throbbing and pulsating pain on one side of the head. Jesduvroq (daprodustat) received a positive opinion from the CHMP for the treatment of adult patients with anaemia associated with chronic kidney disease, a condition in which the kidneys are damaged and cannot filter the blood as well as they should. Negative opinion for a new medicine The CHMP recommended the refusal of a marketing authorisation for Albrioza* (sodium phenylbutyrate/ursodoxicoltaurine) for the treatment of amyotrophic lateral sclerosis, a rare neurological disease affecting nerve cells in the brain and spinal cord that control voluntary muscle movement. For more information on this negative opinion, see the question-and-answer document in the grid below. Withdrawals of applications Applications for the biosimilar medicines Dyrupeg and Zefylti were withdrawn. Both of these medicines were intended for...