EMA Recommends Eight New Medicines for Approval in January

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The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended eight new medicines for approval, issued a positive opinion on one medicine intended for use outside the European Union (EU), and recommended extensions of therapeutic indications for eight other medicines, among other actions taken at CHMP’s Jan. 27–30, 2025 meeting, according to information provided by EMA (1).

Recommendations for marketing authorizations were granted to two medicines. Capvaxive (pneumococcal polysaccharide conjugate vaccine [21-valent]) is intended for the prevention of invasive disease or pneumonia caused by streptococcus pneumoniae bacteria in adults, and Vimkunya (chikungunya vaccine [recombinant, adsorbed]) is designed to protect adults and children aged 12 and older against disease caused by the Chikungunya virus (1).

The following six other new medicines received positive opinions from CHMP:

• Datroway (datopotamab deruxtecan), for treatment of breast cancer
• Dyrupeg (pegfilgrastim), to shorten duration of neutropenia (low levels of neutrophils, a type of white blood cell) and prevent febrile neutropenia after chemotherapy
• Eltrombopag Accord (eltrombopag), for treatment of adults and children with primary immune thrombocytopenia and thrombocytopenia associated with chronic hepatitis C
• Pavblu (aflibercept) and its duplicate Skojoy (aflibercept), indicated for treatment of neovascular age-related macular degeneration and visual impairment
• Tivdak (tisotumab vedotin), for treatment of recurrent or metastatic cervical cancer.

Extensions of indication were recommended for the following medications already authorized in the EU: Breyanzi (lisocabtagene maraleucel), Imfinzi (durvalumab), Opdivo (nivolumab), Ronapreve (casirivimab/imdevimab), Rxulti (brexpiprazole), Sivextro (tedizolid), Slenyto (melatonin), and Yervoy (ipilimumab) (1).

Lisocabtagene maraleucel has been approved in the EU for use in adult patients with various forms of white blood cell cancers, and an indication expansion was already granted by EMA in August 2024 for treatment of relapsed or refractory follicular lymphoma (2). Durvalumab was one of two medications to receive a positive recommendation in January 2025 from the National Institute for Health and Care Excellence for treatment of lung cancer in patients in England and Wales (3). A previous extension of therapeutic indication was given to Slenyto by CHMP in July 2024 (4).

In August 2024 in the United States, FDA accepted the combination of nivolumab plus ipilimumab as a potential first-line treatment for adult patients with unresectable hepatocellular carcinoma (5).

Ivermectin/albendazole received a positive opinion for treatment of infections caused by several worm parasites—including the tropical disease lymphatic filariasis—having been submitted under the EU-Medicines for all program, which enables EMA to contribute to the protection and promotion of public health beyond the EU (1). In March 2021, EMA advised against the use of ivermectin for prevention or treatment of COVID-19 outside of well-designed clinical trials (6).

Finally, the European Commission has asked CHMP to consider information on the safety of Leqembi (lecanemab) that became available after a positive opinion given in November 2024 was adopted (1,7). And applications for marketing authorizations were withdrawn for two medicines: Datopotamab deruxtecan, for the treatment of adults with non-squamous non-small cell lung cancer, and Nugalviq, intended for the treatment of classic galactosaemia (1).

References

1. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 27-30 January 2025. Press Release. Jan. 31, 2025.
2. Bristol Myers Squibb. European Medicines Agency Validates Bristol Myers Squibb’s Application for CAR T Cell Therapy Breyanzi for Relapsed or Refractory Follicular Lymphoma. Press Release. Aug. 19, 2024.
3. AstraZeneca. AstraZeneca Receives Two Positive NICE Recommendations for Lung Cancer Patients Across England and Wales. Press Release. Jan. 22, 2025.
4. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 22–25 July 2024. Press Release. July 26, 2024.
5. Bristol Myers Squibb. Bristol Myers Squibb Receives US Food and Drug Administration sBLA Acceptance for First-Line Treatment of Unresectable Hepatocellular Carcinoma. Press Release. Aug. 21, 2024.
6. EMA. EMA Advises Against Use of Ivermectin for the Prevention or Treatment of COVID-19 Outside Randomized Clinical Trials. Press Release. March 22, 2021.
7. Eisai. Eisai Receives Positive Opinion from the CHMP in the European Union for Lecanemab in Early Alzheimer’s Disease. Press Release, Nov. 15, 2024.