RE:EU approves first I/O combinationThe European Medicines Agency (EMA) said it recommended 77 drugs for marketing authorization last year.
The list of drugs recommended for authorization by EMA's Committee for Medical Products for Human Use (CHMP) includes 39 new active substances, 17 orphan drugs, 8 biosimilars, 15 generics, and 3 drugs that were recommended under accelerated assessments.
The report highlighted the recommendation of new drugs that represented important contributions to public health in several therapeutic areas, including cancer, cardiovascular disease, hematology, metabolism, and neurology.
Under the accelerated assessment pathway, EMA recommended the authorization of two RSV vaccines, Abrysvo (bivalent, recombinant) and Arexvy (recombinant, adjuvanted), as well as Talvey (talquetamab), to treat adults with relapsed and refractory multiple myeloma.
Accelerated assessment “is reserved for medicines that can address unmet medical needs,” the agency noted. “It allows for faster assessment of eligible medicines by EMA’s scientific committees (within a maximum of 150 days rather than 210 days).”
https://www.raps.org/news-and-articles/news-articles/2024/1/ema-approved-77-drugs,-rejected-3-in-2023