EMA Gives Approval to Biosimilars and Several Cancer Treatments

On Sept. 20, 2024, the European Medicines Agency (EMA) announced that its Committee for Human Medicinal Products (CHMP) has recommended approval for eight new medicines and extended indications for an additional 12 drugs. The approvals include drugs for the treatment of cancers, hemophilia, meningococcus, and two biosimilars for treating age-related macular degeneration.

The recommended cancer treatments include Elahere (mirvetuximab soravtansine) for the treatment of ovarian cancer, fallopian tube cancer, or primary peritoneal cancer. Hetronifly (serplulimab) was approved for treating extensive-stage small-cell lung cancer. The generic medicine, Pomalidominde Teva (pomalidomide), was approved to treat the rare bone marrow cancer, multiple myeloma, that impacts plasma cells that produce antibodies.

Other medicines that received recommendations include the following:

• Hympavzi (marstacimab), to treat bleeding episodes in patients 12 years old and above with severe hemophilia A or B
• Penbraya, a vaccine for immunization against Neisseria meningitidis
• Theralugand (lutetium (177lu) chloride), for radiolabeling of carrier medicines developed for radiolabeling with lutetium chloride
• Biosimilars, Afqlir (aflibercept) and Opuviz (aflibercept), for the treatment of age-related macular degeneration.

Updates to COVID-19 messenger RNA vaccines Spikevax (to target the SARS-CoV-2 JN.1 variant) and Comirnaty (for the KP.2 subvariant) were also given positive opinions by CHMP.

“The revision of these vaccines is in line with the recommendations issued by EMA’s Emergency Task Force to update COVID-19 vaccines to target the SARS-CoV-2 variants for the 2024/2025 vaccination campaign,” the agency stated in the press release (1,2).

CHMP also extended indications for the mpox vaccine, Imvanex, as well as Aflunov, Buccolam, Darzalex, Dupixent, Esperoct, Fasenra, Keytruda, Otezla, Pravafenix, Synjardy, and Zavicefta.

CHMP also confirmed its refusal to grant authorization to Syfovre (pegcetacoplan). The committee is also planning to re-examine its opinion of Leqembi (lecanemab) at the request of the applicant.

These approvals bring the 2024 yearly total of positive opinions for new medicines to 79. There have been four negative opinions in 2024 so far, and 63 extensions of indications.

In addition, EMA announced that Bruno Sepodes, a specialist in pharmacology, has been elected as the new chair of CHMP. He has a been a member and vice-chair of CHMP in the past, as well as a member of the agency’s Committee for Advanced Therapies, Committee for Orphan Medicinal Products, and the Emergency Task Force.

“As chair of the CHMP, my number one priority is ensuring the highest standards of medicine quality, safety and efficacy for patients in the European Union (EU),” said Sepodes in a press release (3). “Together, we will address the challenges and opportunities presented by novel technologies, including complex advanced therapies, the integration of digital health technologies and the use of artificial intelligence. We strive to facilitate rapid development and deployment of medicines, in particular when faced with health threats. Advancing regulatory science to support more efficient and evidence-based decision making remains crucial to deliver for patients across the EU."

Sepodes will begin a three-year term on Sept. 21, 2024.

References

1. EMA. Meeting Highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 September 2024. Press Release. Sept. 20, 2024.

2. EMA. EMA Confirms its Recommendation to Update the Antigenic Composition of Authorized COVID-19 Vaccines for 2024-2025. Statement. July 19, 2024. https://www.ema.europa.eu/en/documents/other/ema-confirms-its-recommendation-update-antigenic-composition-authorised-covid-19-vaccines-2024-2025_en.pdf

3. EMA. EMA’s Human Medicines Committee Elects New Chair. Press Release. Sept. 18, 2024.