EMA Recommends Seven Medicines for Approval

September 18, 2020

The EMA recommendations include a meningococcal vaccine and the biosimilar Nyvepria.

The European Medicines Agency announced on Sept. 18, 2020 that its human medicines committee (CHMP) has recommended approval for Exparel (bupivacaine), for the treatment of post-operative pain; MenQuadfi (meningococcal group A, C, W and Y conjugate vaccine), to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroups A, C, W and Y; and Supemtek (Quadrivalent Influenza Vaccine). Market authorization under exceptional circumstances was recommended for the anthrax treatment, Obiltoxaximab SFL (obiltoxaximab). CHMP also gave a positive opinion to the biosimilar Nyvepria (pegfilgrastim) “for reducing the duration of neutropenia and the incidence of febrile neutropenia in patients treated with cytotoxic chemotherapy.”

Market authorization was recommended for the anticoagulant Rivaroxaban Accord (rivaroxaban). Rivaroxaban Accord is a generic drug used to treat and prevent venous thromboembolism, pulmonary embolism, and the prevention of atherothrombotic events. Marketing authorization was also recommended for Phelinun (melphalan) for treatment of “certain haematological and other cancers and as reduced intensity conditioning treatment prior to allogeneic haematopoietic stem cell transplantation in haematological diseases in adults and children. Hybrid applications rely in part on the results of pre-clinical tests and clinical trials of an already authorized reference product and in part on new data,” according to an EMA press release.

CHMP also gave 15 recommendations on extensions of therapeutic indication, includingDeltyba, Flucelvax Tetra, Fycompa, Lynparza, Opdivo, Symkevi, Tecentriq, Velphoro, Yervoy, Zavicefta, Zejula and two extensions of indication for Kalydeco. The committee recommended an extension of indication to Olumiant (baricitinib), to include thetreatment of moderate to severe atopic dermatitis in adult patients who are candidates for systemic therapy. Orfadin (nitisinone)was recommended for an extension of indication to include the treatment of alkaptonuria in adults.

During its September 2020 meeting, CHMP also confirmed its April 2020 opinion on the suspension of all ranitidine drugs in the European Union because of N-nitrosodimethylamine (NDMA) impurity.

Source: EMA