Bumper activity at EMA/CHMP July meeting

At its July meetings this week, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) recommended nine novel medicines for approval, including a medicine for use in countries outside the European Union and one biosimilar.

The CHMP's positive opinions will now be reviewed by the European Commission (EC), with a final decision on the Marketing Authorization Application expected in the coming months.

The CHMP adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine) used to reduce the risk of infection with the human immunodeficiency virus type 1 (HIV-1), in combination with safer sex practices when oral pre-exposure prophylaxis is not used, cannot be used or is not available. Placed in the vagina, the ring slowly releases the antiretroviral medicine dapivirine over a period of 28 days. The submission came from the International Partnership for Microbicides (IPM). This is the eleventh medicine recommended by EMA under the EU Medicines for all (EU-M4All), a mechanism that allows the CHMP to assess and give opinions on medicines that are intended for use in countries outside the European Union under Article 58 of Regulation (EC) No 726/2004.