- Gilead's new combination HIV-1 med Descovy moved one step closer to European approval, winning a positive opinion from the scientific committee of the European Medicines Agency on Thursday.
- Descovy includes the antiretrovirals emtricitabine and tenofovir alafenamide (TAF), Gilead's new version of the tenofovir disoproxil (TDF) used in its existing Viread. TAF has shown similar efficacy to TDF but at roughly 1/10th of the dosage due to improved efficiency in how the drug enters HIV cells.
- The EMA's recommendation will send Gilead's application to the European Commission (EC) for final approval. Decisions by the EC are usually issued a little over two months after the EMA issues its opinion.
The new version of tenofovir present in the drug, TAF, is the backbone of several drugs moving through Gilead's pipeline. In November 2015, the FDA approved Genvoya, a once daily pill for the treatment of HIV-1 which includes two other active ingredients in addition to TAF and emtricitabine. Gilead has an additional two drugs for the treatment of HIV which also rely on TAF, one is awaiting approval in both the U.S. and E.U.
Earlier this week, Gilead announced the results of a switching study comparing Descovy to Truvada, which contains emtricitabine and the older TDF. In a 663 randomized blind trial, Descovy showed similar virologic suppression rates, but with better renal and bone density outcomes through 48 weeks.
Gilead has also submitted Descovy to the FDA for approval in the U.S. It has a PDUFA data of April 7, 2016.
Recently, Gilead has come under fire from the AIDS Healthcare Foundation, which claims Gilead deliberately delayed the introduction of TAF in order to maximize the patent life of its HIV franchise (TDF loses patent protection in December 2017). AHF filed a lawsuit in January attempting to invalidate the patents on the new drugs including TAF. For its part, Gilead stands by the validity of its patents, according to the NY Times.