Gilead Sciences Inc’s Descovy has been approved by FDA on Wednesday. It is a combination drug used to reduce the risks of HIV in men and in transgender women having sex with men. Descovy is the combination of tenofovir alafenamide and emtricitabine and has been approved for the treatment of chronic HIV.
To assess Descovy’s efficacy for PrEP (pre-exposure prophylaxis) in men as well as transgender women having sex with men, the panel had voted 16–2 in its favor. This patient population constitutes the biggest component of PrEP market. This approval has come as a benefit for Gilead as Truvada, which was their third best-selling drug for HIV, has been facing exclusivity loss in US. Geoffrey Porges, SVB Leerink analyst said that Truvada has been greatly boosted by PrEP (pre-exposure prophylaxis) use. There was a 15% growth in Truvada the previous year because of PrEP. He said that the entry of Descovy into the PrEP market which is still underpenetrated is very important for Gilead to retain their Patient base of Truvada after it went off-patent. About 20.5% of the total sales of the HIV franchise were accounted by Truvada in the year 2018.
The panel has said that there was not sufficient data for supporting Descovy’s expansion as a HIV prevention drug in cisgender women. The panel had voted 10-8 in this particular patient population against the approval. Michael Yee, Jefferies analyst said that less than 7% of the PrEP is formed by cisgender women and the drug sales will not be much impacted because of the fact that Descovy’s label has not included cisgender women population.
The decision on approval of Descovy for PrEP is yet to be made by the FDA. Although the FDA is not really bound to go by the advice of the advisory panels, which is what happens most of the time.