The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) concluded its meetings for November and December 2024, recommending several new medicines for approval and расширения the indications of existing ones, marking a significant step in addressing unmet medical needs across various therapeutic areas.
New Medicines Recommended for Approval
In November, the CHMP recommended eight new medicines for approval. Among these was Augtyro (repotrectinib), a conditional marketing authorization for treating adults and adolescents with advanced solid tumors and adults with locally advanced or metastatic non-small cell lung cancer. Lazcluze (lazertinib) also received a positive opinion for first-line treatment of adult patients with advanced non-small cell lung cancer in combination with amivantamab. Gohibic (vilobelimab) received a marketing authorization under exceptional circumstances for SARS-CoV-2-induced acute respiratory distress syndrome.
In December, the CHMP recommended seventeen new medicines for approval, bringing the total for 2024 to 114. Key approvals included Andembry (garadacimab) for preventing recurrent attacks of hereditary angioedema and Beyonttra (acoramidis) for treating transthyretin amyloidosis with cardiomyopathy. Kavigale (sipavibart), a monoclonal antibody, received a positive opinion for preventing COVID-19 in immunocompromised individuals. Rytelo (imetelstat) received a positive opinion for treating transfusion-dependent anemia due to myelodysplastic syndromes.
Extensions of Therapeutic Indication
The CHMP recommended extensions of indication for 11 medicines in November, including Keytruda, Opdivo, and Tagrisso, expanding their use to treat additional conditions or patient populations. In December, eight medicines received recommendations for expanded use, including Ofev for progressive fibrosing interstitial lung diseases (ILDs) in children and adolescents.
Re-examinations and Other Updates
The CHMP re-examined its initial opinion and recommended granting a marketing authorisation for Leqembi (lecanemab), for the treatment of mild cognitive impairment or mild dementia due to Alzheimer’s disease in patients who have only one or no copy of ApoE4. The committee also updated advice to minimize risks of interaction between Mysimba (naltrexone/bupropion) and opioid-containing medicines.
Following the recommendation for approval of Kavigale, EMA’s Emergency Task Force (ETF) issued an updated statement on the loss of activity of anti-spike protein monoclonal antibodies due to emerging SARS-CoV-2 variants.
An application for Izelvay (avacincaptad pegol) intended for the treatment of geographic atrophy caused by age-related macular degeneration was withdrawn. The marketing authorization holder for Alofisel (darvadstrocel) considered that it was not possible for them to provide additional data on the effectiveness of the medicine as expected by EMA, it has decided to withdraw the medicine from the EU market.
