EMA Recommends Seven Medicines for Approval in October

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The European Medicines Agency (EMA) announced on Oct. 13, 2023 that the agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended seven new medicines for the treatment of a variety of conditions, including Duchenne muscular dystrophy, relapsed or refractory multiple myeloma, hyperargininemia, invasive candidiasis,menopause symptoms, and diagnostic medicines for characterizing lesions. EMA also announced two withdrawn marketing applications—for Jivadco and Sugammadex Lorien—and reexamination requests for Translarna and Blenrep. A review of the benefits and risks of Ocaliva (obeticholic acid), which treats adults with primary biliary cholangitis, was also initiated.

Among the positive opinions granted by CHMP is a treatment for Duchenne muscular dystrophy, Agamree (vamorolone), which is a genetic disorder with progressive loss of muscle function. Elrexfio (elranatamab) was approved for the treatment of adult patients with relapsed or refractory multiple myeloma, a rare cancer of the bone marrow.  A positive opinion under exceptional circumstances was granted to Loargys (pegzilarginase) for the treatment of a rare disease with neurological clinical signs, hyperargininemia. Rezzayo (rezafungin) was granted approval for the treatment of invasive candidiasis, a serious fungal infection caused by Candida. In addition, a treatment for moderate-to-severe hot flashes due to menopause—Veoza (fezolinetant)—was approved.

Two diagnostic medicines for the detection of central nervous system lesions—Elucirem (gadopiclenol) and Vueway—were also approved. CHMP also extended indications for Brukinsa, Imfinzi, Jemperli, Keytruda, Praluent, Prevymis, Rubraca, and Veyvondi.

Source: EMA