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EMA's CHMP has adopted a positive opinion for Dapivirine Vaginal Ring for women in non-EU countries where HIV disease burden is high.
The Committee for Human Medicinal Products (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion for Dapivirine Vaginal Ring (dapivirine) for women in non-European Union countries where HIV disease burden is high.
According to a July 24, 2020 press release, this recommendation marks the eleventh to be done under EU Medicines for all (EU-M4All), which is a mechanism that allows CHMP to assess and give opinions on medicines not intended for use in the EU.
The vaginal ring is intended for use in women in non-EU countries where HIV disease burden is high, and where oral pre-exposure prophylaxis is not used, cannot be used, or is not available. After being placed within the vagina, the ring works by slowly releasing dapivirine (an antiretroviral medicine) over a period of 28 days.
CHMP’s positive opinion has been based on safety and efficacy data obtained in a randomized clinical study of 1959 women who had either been assigned to a Dapivirine Vaginal Ring or a placebo ring. The Dapivirine Vaginal Ring was found to lead to a 35% reduced development of HIV-1 antibodies-a measure of presence of HIV in the body-compared with placebo. CHMP is looking for further safety and efficacy data in younger women (18 to 25 years old) and on resistance testing in women who become HIV positive (seroconverters).