Eleven medicines backed for EU approval
The European Medicines Agency human medicines committee (CHMP) has backed eleven medicines for approval at its July 2020 meeting, including a medicine for use in countries outside the region and a novel treatment for multiple myeloma.
The Dapivirine Vaginal Ring (dapivirine), developed by the International Partnership for Microbicides Belgium to reduce the risk of infection with HIV-1 in combination with safer sex practices when oral pre-exposure prophylaxis is not used, 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.
In some areas of the world, such as sub-Saharan Africa, women are particularly vulnerable to being exposed to HIV as they cannot negotiate the use of protective methods during sexual encounters or cannot access oral PrEP. The Dapivirine Vaginal Ring is an option for the prevention of HIV infection that women can control and use discreetly in case they cannot use or do not have access to oral PrEP.
Elsewhere, the Committee recommended a conditional marketing authorisation for GlaxoSmithKline's 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.
Blenrep was accepted in the EMA’s PRIME scheme and, as such, has benefited from the extra support offered by the Agency to medicines that have a particular potential to address patients' unmet medical needs.
The drug has a new mechanism of action that targets B-cell maturation antigen (BCMA), a protein that is present on the surface of virtually all multiple myeloma cells but absent from normal B-cells, making it an ideal drug target.
The recommendation is based on data from the pivotal DREAMM-2 study, in which treatment with Blenrep, administered as a 2.5 mg/kg dose every three weeks (Q3W), resulted in an overall response rate of 32%. Median duration of response was 11 months and median overall survival was 13.7 months.
In order to better characterise the effectiveness and safety of the medicine, GSK will have to submit the results of a randomised confirmatory (Phase III) trial comparing Blenrep with pomalidomide plus low-dose dexamethasone, which is a standard treatment option for relapsed and refractory multiple myeloma.
Also backed for approval by the CHMP were: Novartis' Adakveo (crizanlizumab), for the prevention of recurrent vaso-occlusive crises in patients with sickle cell disease; Insmed's Arikayce liposomal (amikacin), for non-tuberculous mycobacterial lung infections caused by Mycobacterium avium Complex in adults with limited treatment options who do not have cystic fibrosis; Blueprint Medicines' Ayvakyt (avapritinib), for adults with unresectable or metastatic gastrointestinal stromal tumours harbouring the platelet-derived growth factor receptor alpha D842V mutation; AstraZeneca's Calquence (acalabrutinib) for tchronic lymphocytic leukaemia; Gilead's Jyseleca (filgotinib) for the treatment of rheumatoid arthritis; and Heron's Zynrelef (bupivacaine/meloxicam) for the treatment of post-operative pain.
Centus Biotherapeutics' biosimilar 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, while the generics Arsenic trioxide medac (arsenic trioxide) and Fampridine Accord (fampridine) were backed for acute promyelocytic leukaemia and multiple sclerosis patients with walking disability, respectively.
On the downside, negative opinions were issued for Stemline Therapeutics' Elzonris (tagraxofusp) and Swedish Orphan Biovitrum AB' Gamifant (emapalumab).
Elzonris has been developed for the treatment of blastic plasmacytoid dendritic cell neoplasm, a rare and aggressive type of acute myeloid leukaemia, while Gamifant was expected to be used to treat primary haemophagocytic lymphohistiocytosis, a genetic disease characterised by an overactive immune system.