At its May meeting, the European Medicines Agency's drug advisory body recommended 14 new medicines for approval, including one biosimilar and five generics, while it also backed extended labelling for seven treatments. In addition, the Committee for Medicinal Products for Human Use (CHMP) confirmed a negative opinion following a re-examination, and there were two marketing application withdrawals. All of the decisions can be found detailed below. Positive recommendations on new medicines:
Eckert & Ziegler’s GalliaPharm (germanium [68Ge] chloride / gallium [68Ga] chloride) for radiolabelling of various kits used for positron emission tomography (PET) imaging. Valneva’s Ixchiq (chikungunya vaccine [live]) to protect adults against disease caused by Chikungunya virus transmitted to humans by infected mosquitoes. Bio-Thera Solutions’ biosimilar version of Avastin (bevacizumab), named Avzivi, for the treatment of carcinoma of the colon or rectumcarcinoma of the colon or rectum, breast cancer, NSCLC, renal cell cancer, epithelial ovarian, fallopian tube or primary peritoneal cancerepithelial ovarian, fallopian tube or primary peritoneal cancerepithelial ovarian, fallopian tube or primary peritoneal cancer, and carcinoma of the cervix. Positive recommendations on extensions of therapeutic indication:
AbbVie’s Skyrizi (risankizumab) for the treatment of adults with moderately to severely active UC who have had an inadequate response, lost response, or were intolerant to either conventional or biologic therapy. Negative opinions on new medicines:
Withdrawal of applications:
Clinuvel withdrew an application to expand use of Scenesse (afamelanotide) into adolescents with erythropoietic protoporphyria. The drug has been approved in this indication in the EU since 2014 for adults. However, the company determined that it was not possible to provide the comprehensive safety and efficacy data expected by the EMA in the expanded population.