From their meeting in July, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) has published the highlights.
July’s meeting saw eleven medicines recommended for approval including two new medicines, five orphan medicines, one biosimilar, and two generics.
Dapivirine Vaginal Ring (dapivirine) was recommended under the “EU Medicines for All” scheme, a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the EU under Article 58 of Regulation (EC) No 726/2004. Dapivirine is used to reduce the risk of HIV type 1 infection in combination with safer sex practices, and when oral pre-exposure prophylaxis cannot be used.
A conditional marketing authorisation was recommended for Blenrep (belantamab), a new antibody drug conjugate for adult patients with relapsed or refractory myeloma. This medicine benefited from the support of the PRIME scheme. Further marketing authorisations were recommended for Adakveo (crizanlizumab), for the prevention of recurrent vaso-occlusive crises in sickle cell disease, Ayvakyt (avapritinib), for unresectable or metastatic gastrointestinal stromal tumours and Zynrelef (bupivacaine/meloxicam) for the treatment of post-operative pain.
CHMP adopted positive opinions for Arikayce liposomal (amikacin) for non-tuberculous mycobacterial lung infections caused by Mycobacterium avium Complex, Calquence (acalabrutinib) for chronic lymphocytic leukaemia and Jyseleca (filgotinib) for rheumatoid arthritis.
The biosimilar Equidacent (bevaciumab) received a positive opinion for various types of cancers. Two generic medicines were recommended for marketing authorisations. Arsenic trioxide Medac for acute promyelocytic leukaemia and Fampridine Accord for improvement of symptoms associated with multiple sclerosis with walking disability.
Additionally, there were nine recommendations for extensions of therapeutic indications, including Crysvita, HyQvia, Imbruvica, Imfinzi, Kalydeco, Latuda, NovoThirteen, Prezista and Shingrix.
However, there were two negative opinions adopted by the CHMP, for Elzonris (tagraxofusp) and Gamifatn (emapalumab) (pexidartinib). Applications for initial marketing authorisations for Rayqota (abicipar pegol) and Abilify MyCite (aripiprazole) were withdrawn.
Fortacin (lidocaine/prilocaine) for primary premature ejaculation, was recommended for a change to non-prescription status.
CHMP also started a review of the RECOVERY study which involves dexamethasone in the treatment of hospitalised COVID-19 patients.
A detailed report of the meeting outcomes can be found here.