EMA recommends 11 new medicines for approval following July meeting

The European Medicines Agency’s (EMA) human medicines committee (CHMP) has recommended eleven medicines for approval at its July 2020 meeting, including a medicine for use in countries outside the EU.

The CHMP adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine), used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV-1), in combination with safer sex practices when oral pre-exposure prophylaxis is not used, cannot be used or is not available. Placed in the vagina, the ring slowly releases the antiretroviral medicine dapivirine over a period of 28 days.

This is the eleventh medicine recommended by EMA under EU Medicines for all (EU-M4All), a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the EU. 

The Committee recommended granting a conditional marketing authorisation for Blenrep (belantamab mafodotin), a new antibody-drug conjugate for adult patients with relapsed and refractory multiple myeloma who no longer respond to treatment with an immunomodulatory agent, a proteasome inhibitor and a CD-38 monoclonal antibody. 

The CHMP gave a positive opinion for Adakveo (crizanlizumab) for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease and Arikayce liposomal (amikacin) for the treatment of non-tuberculous mycobacterial lung infections caused by Mycobacterium avium Complex in adults with limited treatment options who do not have cystic fibrosis.

Ayvakyt (avapritinib), for the treatment of adult patients with unresectable or metastatic gastrointestinal stromal tumours harbouring the platelet-derived growth factor receptor alpha D842V mutation, was also recommended for marketing authorisation. 

The Committee adopted a positive opinion for Calquence (acalabrutinib) for the treatment of chronic lymphocytic leukaemia, a type of cancer affecting white blood cell called lymphocytes as well as Jyseleca (filgotinib) for the treatment of rheumatoid arthritis.

The CHMP further recommended granting a marketing authorisation for Zynrelef (bupivacaine/meloxicam) for the treatment of post-operative pain.

The biosimilar medicine Equidacent (bevacizumab) received a positive opinion for the treatment of carcinoma of the colon or rectum, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer and carcinoma of the cervix.

Two generic medicines were recommended for marketing authorisation: Arsenic trioxide medac (arsenic trioxide), for the treatment of acute promyelocytic leukaemia (blood cancer) and Fampridine Accord (fampridine), intended to improve walking of adult patients suffering from multiple sclerosis with walking disability.

The Committee recommended extensions of indications for Crysvita, HyQvia, Imbruvica, Imfinzi, Kalydeco, Latuda, NovoThirteen, Prezista and Shingrix.

The CHMP also announced it has started a review of the results from the RECOVERY study arm that involved the use of dexamethasone in the treatment of patients with COVID-19 admitted to hospital. The review aims to provide an opinion on the results of the study and in particular the potential use of dexamethasone for the treatment of adults with COVID-19. 

Negative opinions

However, the CHMP adopted negative opinions recommending the refusal of marketing authorisations for Elzonris (tagraxofusp) and Gamifant (emapalumab).

The Committee recommended the suspension of the marketing authorisations of generic medicines tested by Panexcell Clinical Laboratories at its site in Mumbai, India. The recommendation comes after Austrian and German inspectors found irregularities in how the company carried out bioequivalence studies, which are used to show that a generic medicine produces the same amount of active substance in the body as the reference medicine.