The European Medicines Agency has recommended that two new drugs be approved for marketing in the EU – AbbVie’s Aquipta (atogepant monohydrate), for the prophylaxis of migraine, and GSK’s Jesduvroq (daprodustat), for treating adults with anemia associated with chronic kidney disease (CKD).
On the other hand, the agency said that Amylyx Pharmaceuticals’ Albrioza should not be approved for treating amyotrophic lateral sclerosis in the EU. Amylyx is planning to appeal against the EMA’s decision on the drug, which is approved in the US and in Canada (with conditions)