The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended seven new medicines for approval in its latest meeting.
This includes a positive opinion for Pacira BioScience’s non-opioid drug Exparel (bupivacaine) for the treatment of post-operative pain. Following the CHMP opinion, Pacira expects the European Commission to adopt a final decision on Exparel in November.
“This positive CHMP opinion brings Pacira one step closer to realizing our vision of establishing Pacira as the global leader in innovative non-opioid pain management,” said Dave Stack, chief executive officer and chairman of Pacira.
The Committee also recommended granting marketing authorisation for two new vaccines – Sanofi’s MenQuadfi for the prevention of invasive meningococcal disease in persons two years of age and older, as well as the French pharma’s Sepertek vaccine for prophylaxis against influenza.
Under exceptional circumstances, the CHMP granted a marketing authorisation for Obiltoxaximab SFL (obiltoxaximab), for the treatment or post-exposure prophylaxis of inhalational anthrax.
This type of marketing authorisation is granted when there is not enough data on the efficacy and safety of a medication under normal conditions of use, because it alleviates a condition that is rare or full information is not possible or ethical.
Pfizer’s biosimilar to Amgen’s Neulasta (pegfilgrastim) Nyvepria (pegfilgrastim-apgf) also received a positive opinion for reducing the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy.
Rounding out this month’s recommendations were Accord’s generic anticoagulant med Rivaroxaban, and Phelinun (melphalan) – a hybrid medication for the treatment of haematological and other cancers, and as a reduced intensity conditioning treatment given prior to allogeneic haematopoietic stem cell transplantation.