Evrysdi leads latest CHMP recommendations

The European Medicines Agency’s (EMA) Committee for Medicines for Human Use (CHMP) has recommended six medicines for approval at its February meeting.

The first to receive a positive opinion is PTC Therapeutics’ Evrysdi (risdiplam) for the treatment of certain types of spinal muscular atrophy (SMA).

SMA is a rare and often fatal genetic disease that causes muscle weakness and progressive loss of movement.

The CHMP review of Evrysdi was completed under the accelerated assessment pathway, which is used for medicines determined to be of major interest for public health and therapeutic innovation.

GlaxoSmithKline’s (GSK) Jemperli (dostarlimab) also scored a recommendation from the CHMP for the treatment of certain types of recurrent or advanced endometrial cancer.

Further, BioCryst received a positive opinion for Orladeyo (berotralstat) for the prevention of recurrent attacks of hereditary angioedema (rapid swelling under the skin).

The CHMP also recommended two biosimilar medicines – Mylan’s Abevmy (bevacizumab) and Lextemy (bevacizumab) – for the treatment of colon or rectum cancer, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancer and cervix cancer.

The generic medicine Abiraterone Accord (abiraterone) also received a positive opinion for the treatment of metastatic prostate cancer.

A number of medicines also received recommendations for label extensions, including Ipsen’s Cabometyx (cabozantinib), GW Pharma’s cannabidiol Epidyolex, Bristol Myers Squibb’s (BMS) checkpoint inhibitor Opdivo (nivolumab), Quofenix (delafloxacin) and Sanofi’s Sarclisa (isatuximab).

The CHMP also completed its review of Regeneron’s monoclonal antibody combination treatment for COVID-19, REGN-COV2 (casirivimab and imdevimab).

The Committee concluded that the therapy can be used for the treatment of COVID-19 in patients who do not require supplemental oxygen and who are at high-risk of progressing to severe COVID-19.