CHMP’s February recommendations: Evrysdi, Jemperli, and a generic for prostate cancer

Regulatory NewsRegulatory News | 26 February 2021 |  By 

The European Medicines Agency’s Committee for Medicinal Products for Human Use (EMA’s CHMP) recommended six new medicines for approval when it met in February, including two biosimilars and one generic medicine.
The committee recommended marketing authorization for Roche’s Evrysdi (risdiplam) for the treatment of certain types of spinal muscular atrophy (SMA). It is the first oral treatment for this condition and was reviewed under the EMA’s accelerated assessment program. It is indicated for the treatment of 5q SMA in patients at least 2 months of age with Type 1, 2, or 3 SMA or with one to four SMN2 copies.
The committee recommended conditional marketing authorization for GlaxoSmithKline’s Jemperli (dostarlimab) as monotherapy for the treatment of adults with certain types of recurrent or advanced endometrial cancer that has progressed on or following prior treatment with a platinum-containing regimen.
BioCryst’s Orladeyo (berotralstat) received a positive opinion for the prevention of recurrent attacks of hereditary angioedema in adults and adolescents aged 12 years and older. The committee also issued positive opinions for two bevacizumab biosimilars from Mylan IRE Healthcare: Abevmy and Lextemy, both of which treat 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.
A generic medicine to treat metastatic prostate cancer, Accord Healthcare S.L.U.’s Abiraterone Accord (abiraterone), also received a positive opinion from the committee. Abiraterone Accord is a generic formulation of Janssen-Cilag’s Zytiga, which was authorized in the EU in 2011.
The committee endorsed indication extensions for five medicines: Cabometyx (cabozantinib, Ipsen Pharma), Epidyolex (cannabidiol, GW Pharma), Opdivo (nivolumab, Bristol-Myers Squibb), Quofenix (delafloxacin, A. Menarini), and Sarclisa (isatuximab, sanofi-aventis groupe).
But the committee issued a negative opinion on adding the treatment of patients with asthma to the indication for GlaxoSmithKline’s triple therapies Elebrato Ellipta, Temybric Ellipta, and Trelegy Ellipta (fluticasone furoate/ umeclidinium/ vilanterol). The EMA recommended against the change in marketing authorization for these medicines because the main study underlying the marketing application showed only an improvement in lung function, but not a reduction in asthma attacks or symptoms.
The committee completed an outcome review for the varicella vaccine Varilrix (live attenuated varicella virus [OKA strain]). The committee recommended changes to the prescribing information for Varilrix to harmonize its use in the EU. The changes would allow it to be given from the age of 12 months and in some cases for infants starting at 9 months of age.
Article 5(3) advice on REGN-COV2
The committee also issued advice on the use of Regeneron’s COVID-19 monoclonal antibody treatment REGN-COV2 (casirivimab and imdevimab), concluding that the combination could be used for the treatment of patients with confirmed COVID-19 who do not require supplemental oxygen and who are at high risk for progressing to severe disease.
The review of REGN-COV2 was initiated under Article 5(3) of Regulation (EC) No 726/2004, which allows EMA to provide harmonized scientific opinions on the medicines to support decisions on their use at the national level in the EU before they are formally authorized. EMA is currently conducting a rolling review of REGN-COV2, which will yield a recommendation on EU-wide marketing authorization for the medicine.
The committee also reviewing the antibodies bamlanivimab and etesevimab under the Article 5(3) procedure, but that review is still ongoing. (RELATED: EMA reviewing data on four COVID monoclonal antibodies, Regulatory Focus 4 February 2021).


© 2023 Regulatory Affairs Professionals Society.


Discover more of what matters to you

No taxonomy