Rome, 23 September – The Committee for Medicinal Products for Human Use (CHMP) of the EMA recommended the approval of eight new drugs at its last meeting in September. Among the others, the requests to grant marketing authorisation for Elahere (mirvetuximab soravtansine), a drug intended for the treatment of adults with ovarian cancer, fallopian tube cancer or primary peritoneal cancer and Hetronifly (serplulimab), for the treatment of extensive-stage small cell lung cancer. Positive opinion also for Hympavzi (marstacimab), indicated for the treatment of bleeding episodes in patients aged 12 years and older with severe haemophilia A or B, two types of a rare inherited bleeding disorder.
The other CHMP recommendations concern:
- Penbraya, meningococcal groups A, C, W, Y and group B conjugate vaccine (recombinant, adsorbed), indicated for immunization against invasive disease caused by Neisseria meningitidis the Gram-negative bacterium often referred to as meningococcus, which colonizes the upper respiratory tract and can cause severe, life-threatening invasive meningococcal disease in some individuals.
- Theralugand (lutetium chloride 177lu), which must only be used for radiolabelling of carrier medicinal products that have been specifically developed and authorised for radiolabelling with lutetium chloride.
- Afghan (aflibercept) e Opuviz (aflibercept), two biosimilar medicines intended for the treatment of age-related macular degeneration, a progressive retinal macular disease that causes gradual deterioration of vision mainly in older people.
- Pomalidomide Teva (pomalidomide), a generic medicine for the treatment of multiple myeloma, a rare cancer of the bone marrow that affects plasma cells (a type of white blood cell that produces antibodies).
Finally, the CHMP also expressed a positive opinion for an update of the composition of two anti-Covid vaccines: the first is the mRNA vaccine. Spikevax1, targeted on the JN.1 variant of Sars CoV 2: the second Comirnaty, for the KP.2 subvariant.
The review of the two vaccines is in line with the recommendations of the EMA Emergency Task Force aimed at updating the anti-Covid arsenal, in view of the 2024/2025 vaccination campaign, with weapons capable of protecting against new variants of the virus.
In its last meeting, the CHMP also recommended the extension of the therapeutic indications for 12 medicines, above all that of the smallpox vaccine and mpox. Imvanex to adolescents aged 12 to 17 years. The other extensions of use – which obviously concern medicinal products already authorised in the European Union – are for Aflunov, Buccolam, Darzalex, Dupixent, Esperoct, Fasenra, Keytruda, Otezla, Pravafenix, Synjardy e Zavicefta.
