EMA Recommends Several Medicines in October

Text sign showing Industry News. Business photo text delivering news to the general public or a target public | Image Credit: © Artur - © Artur - stock.adobe.com

The European Medicines Agency announced on Oct. 18, 2024 that its Committee for Medicinal Products for Human Use (CHMP) has recommended 10 new medicines for marketing approval, including five new drugs, one orphan drug, two biosimilars, and two generic drugs (1). This brings the total of new medicines receiving positive opinions to 89 in 2024. Extensions for indications were also granted to six drugs.

Two vaccines, Fluad and Flucelax, were approved for immunization against influenza. Fluad is a surface antigen, inactivated, adjuvanted vaccine for use in adults 50 years of age and older. Flucelvax, which is a surface antigen, inactivated and prepared in cell cultures, may be used in adults and children, two years of age and older.

Other approved medicines include:

• Alhemo (concizumab) for routine prophylaxis of bleeding in patients with haemophilia A or B with inhibitors
• Korjuny (catumaxomab) to treat intraperitoneal malignant ascites, “a build-up of fluid containing cancer cells in the abdomen of cancer patients,” according to EMA.
• Siiltibcy (rdESAT-6/rCFP-10) to diagnosis Mycobacterium tuberculosis infection
• Wainzua (eplontersen), designated an orphan drug, to treat adults with hereditary transthyretin-mediated amyloidosis
• Buprenorphine Neuraxpharm (buprenorphine) to treat opioid addiction.

In addition, two biosimilars, Absimky (ustekinumab) and Imuldosa (ustekinumab), were granted positive opinions for the treatment of plaque psoriasis in children and adults, psoriatic arthritis, Crohn’s disease, and ulcerative colitis. The generic drug, Eltrombopag Viatris (eltrombopag), was also recommended for the treatment of children and adults with primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C.

CHMP also recommended extending indications for Cerdelga (eliglustat), Hepcludex (bulevirtide), Kevzara (sarilumab), Kisqali (ribociclib), Tevimbra (tislelizumab), and Yselty (linzagolix choline). Updates to the COVID-19 vaccines Nuvaxovid and Bimervax were also given positive opinions.

At the meeting, CHMP also stated that it is confirming its recommendation, originally issued in June 2024, to refuse authorization for Masitinib AB Science (masitinib) for the treatment of amyotrophic lateral sclerosis after re-examination of the application.

“At the time of the initial evaluation, the agency considered that the study data were not reliable, as findings from good clinical practice inspections coordinated by EMA and other regulatory authorities had identified issues with the conduct of the study that could not be sufficiently addressed by the company. In addition, the benefits of Masitinib AB Science could not be convincingly demonstrated; the study found no difference between the medicine and placebo in the main measure of effectiveness for the total study population and had several methodological issues. These concerns did not change after re-examination of the data provided and following consultation of a group of experts in neurology, as well as patient representatives. In reaching its final decision, the agency also considered information shared by patient organizations (so-called third-party interventions). Therefore, the Agency maintained its opinion that the benefits of Masitinib AB Science did not outweigh its risks and recommended refusing marketing authorization,” the agency stated on its website (2).

 Two drug applications were withdrawn from consideration. Apremilast Viatris (apremilast), to treat plaque psoriasis, active psoriatic arthritis, and mouth ulcers caused by Behçet’s disease, was withdrawn because the agency found that the data provided did not match bioequivalence conclusions. The epilepsy drug, Epixram (levetiracetam), was withdrawn because of a change in the company’s regulatory strategy.

References

1. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 14–17 October 2024. Press Release. Oct. 18, 2024.
2. EMA. Masitinib AB Science. ema.europa.eu. (accessed Oct. 18, 2024).