EMA: Thumbs up for 11, down for 2 new medicines

Regulatory NewsRegulatory News | 24 July 2020 |  By 

At its June 2020 meeting, the human medicines committee of the European Medicines Agency (EMA’s CHMP) recommended that 11 new medicines be approved for use in the European Union (EU); one of these, Dapirivine Vaginal Ring, was recommended under EU Medicines for All, a mechanism for medicines that are also to be used outside the EU.  

Dapirivine Vaginal Ring is meant to reduce the risk of infection with HIV, in situations where oral pre-exposure prophylaxis is not used, cannot be used, or is unavailable. The active antiretroviral ingredient, dapirivine, is released over 28 days.  
The committee also gave out its second and third negative recommendations of the year for Elzonris (tagraxofusp) and Gamifant (emapalumab). Gamifant’s use was to be treatment of primary hemophagocytic lymphohistiocytosis, a genetic disease; Elzonris was to be used to treat blastic plasmacytoid dendritic cell neoplasm, a variant of acute myeloid leukemia.
In both instances, CHMP cited the small sample size of the studies upon which the submissions relied, noting that both efficacy and safety were difficult to determine in such small samples. In addition, for Gamifant, the committee observed that the reliability of study data could not be confirmed.
Addressing the novel coronavirus pandemic, CHMP began its review of the use of dexamethasone to treat hospitalized patients with COVID-19, examining results from the relevant arm of the RECOVERY study. “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,” said CHMP.
A conditional marketing authorization was recommended for Blenrep (belantamab mafodotin), a novel conjugate of antibody and drug meant to treat adults with relapsed and refractory multiple myeloma who have not responded to other specified treatments. Blenrep’s application was aided by EMA’s PRIME scheme, which speeds evaluation and review of therapies that address unmet medical needs.
For adults with Mycobacterium avium lung infections who do not have cystic fibrosis and have limited treatment options, CHMP recommended Arikayce liposomal (amikacin).
Adakveo (crizanlizumab) received a recommendation to prevent recurrent vaso-occlusive crises in patients with sickle cell disease.
Three small molecules, Ayvakyt (avapritinib), Calquence, (acalabrutinib), and Jyseleca (filgotinib), received recommendations to treat unresectable or metastatic gastrointestinal stromal tumors with the platelet derived growth factor receptor alpha D842V mutation, chronic lymphocytic leukemia, and rheumatoid arthritis, respectively.
The combination of bupivacaine and meloxicam, to be marketed as Zynrelef, was recommended to treat post-operative pain.

The biosimilar Equidacent (bevacizumab) was recommended to treat several types of cancers, including colorectal and cervical carcinomas, breast cancer, non-small cell lung cancer, renal cell cancer, and epithelial ovarian, fallopian tube, and primary peritoneal cancer.
Two generics also received a recommendation for marketing authorization. Arsenic trioxide medac (arsenic trioxide) was recommended to treat acute promyelocytic leukemia, and Fampridine Accord (fampridine) was recommended for adults with multiple sclerosis and walking disability, to improve their walking.
Additionally, extended indications were recommended for Crysvita, HyQvia, Imbruvica, Imfinzi, Kalydeco, Latuda, NovoThirteen, Prezista and Shingrix.
A switch from prescription to non-prescription status was recommended for one medication, Fortacin (lidocaine/prilocaine). The committee judged that this topical medicine for the treatment of primary premature ejaculation could safely be used by patients without a prescription.
Finally, CHMP recommended that marketing authorizations for generic medications tested by Panexcell Clinical Laboratories Priv. Ltd at its Mumbai site be suspended. At that site, inspectors from Austria and Germany found problems in the company's bioequivalence studies. Irregularities observed by the inspectors included finding “samples from different patients that were exceptionally similar,” as well as personnel documenting incorrect room temperatures in sample processing areas. “These findings raise serious concerns about the company's quality management system and the reliability of data from that site,” said CHMP. 




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