EMA's committee gave recommendations for marketing authorization of 17 drugs in December, which include therapies for rare heart conditions, anemia, and liver disease.
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Editor's note: this story was originally published on PharmTech.com.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has recommended 17 drugs for market authorization at its December 2024 meeting. These recommendations include five orphan drugs and six biosimilars, EMA announced in a Dec. 13, 2024 press release.
Among the approval recommendations is a monoclonal antibody, Kavigale (sipavibart), for COVID-19 prevention in immunocompromised people aged 12 and older. “Following the recommendation for approval of Kavigale, EMA’s Emergency Task Force (ETF) has issued an updated statement on the loss of activity of anti-spike protein monoclonal antibodies due to emerging SARS-CoV-2 variants and recommends healthcare professionals to check the current epidemiological situation in their region,” the agency stated in a press release (1). Kostaive (zapomeran), a self-amplifying messenger RNA vaccine, was also recommended for the prevention of COVID-19.
Orphan drugs recommended by CHMP include the following:
The following six biosimilars were recommended for authorization:
Other positive opinions given by CHMP include:
The December recommendations bring the total of drugs recommended for approval by CHMP for 2024 to 114.
CHMP also extended recommendations for several drugs, including Ofev for the treatment of progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents, Blincyto, Bridion, Flucelvax Tetra, Jemperli, Omvoh, Rekambys, and Vocabria.
Also during the December meeting, CHMP chose to withdraw Alofisel (darvadstrocel) from the market after data showed its effectiveness was not what had been anticipated. Alofisel had been approved to treat complex anal fistulas in adults with Crohn’s disease.
1. EMA. Meeting highlights from the Committee for Medicinal Products for Human Use(CHMP) 9-12 December 2024. Press Release. Dec. 13, 2024.
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