EMA recommended 77 drugs, rejected 3 in 2023
Editor's note: This article was revised on 17 January 2024 to clarify aspects of the medicines authorization process in the EU.The European Medicines Agency (EMA) said it recommended 77 drugs for marketing authorization last year and recommended against the authorization of three drugs in the European Union, according to a report published on 16 January. The agency also noted that 19 drug applications were withdrawn during the year.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.
As the world continues to tackle respiratory diseases caused by pathogens such as the SARS-CoV-2 virus and the respiratory syncytial virus (RSV), EMA highlighted its work to address emerging diseases and consider novel treatments.
“The agency recommended two vaccines to protect against lower respiratory tract disease caused by respiratory syncytial virus (RSV), and the first advanced therapy medicinal product using a ground-breaking gene-editing technology known as CRISPR/Cas9 to treat two rare blood disorders,” said the agency. “EMA also adopted two positive opinions for medicines for use in countries outside the EU.”
EMA also recomended the Bimervax COVID-19 booster for people 16 and older who have already received an mRNA vaccine, as well as the Comirnaty, Spikevax, and Nuvaxovid vaccines that were adapted to the Omicron XBB.1.5 variant.
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).”
Under the EU-Medicines for All (EU-M4All) program, CHMP also provided a positive opinion for Arpraziquantel (arpraziquantel) to treat children with schistosomiasis, a tropical disease and Fexinidazole Winthrop (fexinidazole), to treat human African trypanosomiasis, also known as sleeping sickness. The program is a collaboration with the World Health Organization (WHO) that allows EMA's regulatory decision to be applied outside its borders.
Eight drugs that received positive opinions from CHMP last year were authorized under conditional marketing authorization, which means they have been allowed early on the market based on less complete clinical data because they address an unmet need. Most of those drugs were for treating cancers, and they must meet postmarket requirements, including providing additional data, to stay on the market.
CHMP gave negative opinions for three drugs, including Albrioza (sodium phenylbutyrate/ ursodoxicoltaurine) to treat amyotrophic lateral sclerosis; Lagevrio (molnupiravir) to treat COVID-19; and Sohonos (palovarotene), to treat fibrodysplasia ossificans progressiva.
EMA 2023 human medicines report
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