Two Generics Companies Apply For First WHO Prequalification Of Novel Antiretroviral

Today, the Medicines Patent Pool announced that two generic drug companies applied for the World Health Organization prequalification of an innovative antiretroviral.

Cipla and Mylan, both MPP manufacturing partners, are the first companies to apply for prequalification of generic dolutegravir, an antiretroviral that the MPP licences from ViiV Healthcare in 2014, according to an MPP press release.

WHO prequalification of Cipla and Mylan is necessary to allow international procurers such as the Global Fund to Fight AIDS, Tuberculosis and Malaria, UNICEF and UNITAID to purchase and distribute the treatment in developing countries, the MPP said.

According to the MPP dolutegravir (DTG) is considered a significant improvement in antiretroviral therapy. ViiV Healthcare granted the MPP two non-exclusive licenses for the generic manufacture of DTG, the press release said, one for the production of the medicine for adults and another for children.

“Both licences permit generic pharmaceutical companies based anywhere in the world to manufacture DTG and to combine the treatment with other drugs to develop fixed-dose combinations of regimens recommended by the WHO,” it said.

Currently, nine MPP licensees are developing DTG as an active pharmaceutical ingredient and in formulations, said the MPP, and they will be submitting dossiers to the WHO prequalification programme and/or the US Food and Drug Administration, some of them very soon.

“Robust competition among MPP licensees will improve access for this key medicine,” said Greg Perry, MPP’s executive director.