EMA recommends six medications for approval in February meeting
The EMA’s committee adopted positive opinions of six medications, including two orphan drugs, and concluded its review of the use of REGN-COV2 – an investigational antibody therapy for COVID-19.
In its February meeting the European Medicines Agency (EMA)’s Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for six medications and reported the findings of its review of REGN-COV2 in hospitalised COVID-19 patients, among other actions.
Six medications recommended for approval
Evrysdi (risdiplam) – the first oral treatment that can be given to patients with certain types of spinal muscular atrophy was recommended for full marketing authorisation. As Evrysdi addresses an unmet medical need, it was supported by the PRIME scheme and reviewed under the accelerated assessment programme.
Jemperli (dostarlimab), a treatment for certain types of recurrent or advanced endometrial cancer was endorsed for conditional marketing approval.
Orladeyo (berotralstat) gained a positive opinion for the prevention of recurrent attacks of hereditary angioedema (rapid swelling under the skin).
The biosimilars Abevmy (bevacizumab) and Lextemy (bevacizumab) were recommended for approval in 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 cervical carcinoma.
Additionally, Abiraterone Accord (abiraterone), a generic medicine, received a positive opinion in metastatic prostate cancer.
The CHMP also reviewed extensions of indication – it advised approving the extensions for Cabometyx, Epidyolex, Opdivo, Quofenix and Sarclisa; however, adopted negative opinions for Elebrato Ellipta (fluticasone furoate/umeclidinium/vilanterol), Temybric Ellipta (fluticasone furoate/umeclidinium/vilanterol) and Trelegy Ellipta (fluticasone furoate/umeclidinium/vilanterol) for patients with asthma.
The committee completed two reviews, one for the Varilrix (live attenuated varicella virus [OKA strain]) vaccine, used for protecting individuals against varicella (chickenpox), and the other for REGN-COV2, a combination of two monoclonal antibodies (casirivimab and imdevimab) for the treatment of patients with COVID-19.
The CHMP recommended changes to the prescribing information for Varilrix. According to EMA, the adaptations are designed to harmonise the way the medicine is used in the EU. Click here to find out more.
In its review of REGN-COV2, the agency was working to provide a harmonised scientific opinion at EU level to support national decision making on the possible use of the antibodies prior to marketing authorisation. EMA concluded that the combination can be used for the treatment of confirmed COVID-19 in patients who do not require supplemental oxygen and who are at high risk of progressing to severe COVID-19.
New pilot project for early contact with patients
The committee also initiated a new pilot programme to enhance engagement with patients at the start of review of all marketing authorisation applications for orphan medicines. The one-year trial will enable patients to share their views on aspects such as quality of life, treatment options and unmet medical needs with the CHMP. Please visit the project overview document for more information.
Abevmy (bevacizumab), Abiraterone Accord (abiraterone), Evrysdi™ (risdiplam), Jemperli (dostarlimab), Lextemy (bevacizumab), Orladeyo (berotralstat), REGEN-COV™ (casirivimab and imdevimab antibody cocktail), Varilrix (live attenuated varicella virus [OKA strain])