EMA gives green light for six new medicines

A total of 67 new medicines have been approved by the European Medicines Agency (EMA) in 2021. This includes six new products backed by the watchdog’s key advisory body, the Committee on Human Medicinal Products (CHMP).

The newly approved products are:

• Trodelvy (sacituzumab govitecan) for the treatment of unresectable or metastatic triple-negative breast cancer.
• Rybrevant (amivantamab), conditionally approved for the treatment of non-small cell lung cancer.
• Aspaveli (pegcetacoplan) for the treatment of adult patients with paroxysmal nocturnal haemoglobinuria.
• Cibinqo(abrocitinib) for the treatment of atopic dermatitis.
• Vaxneuvance(pneumococcal polysaccharide conjugate vaccine (15-valent, adsorbed)), intended for prophylaxis against pneumococcal pneumonia and associated invasive disease.
• Sitagliptin SUN (sitagliptin fumarate), a generic medicine for type 2 diabetes.

The Committee also recommended extensions of indication for Edistride, Forxiga, Hizentra, Kisplyx, Lenvima, Repatha, Skyrizi, Xeljanz, Zeposia and two extensions of indication for Keytruda.