Gilead Sciences, Inc., which is a US-based biotechnology company that is engaged in research, development, and commercialization of drugs. The company announced on 6th August 2019, that they have has submitted a supplemental New Drug Application (sNDA) to the US Food and Drug Administration (USFDA) for Descovy. Which is a combination of emtricitabine 200 mg and tenofovir alafenamide 25 mg tablets. risk of sexually acquired HIV-1 infection among individuals for pre-exposure prophylaxis (PrEP). The experts panel of FDA said Descovy approval for treatment of PrEP in 2 groups of people or patients. The data upkeep the projected PrEP indication for Descovy drug in men, who have intercourse with transgender women or men.
The most information from the briefing documents of Descovy is that drug will be clearly approved as it is used for the treatment of many important indications. As USFDA panel experts raised a question that Gilead’s Descovy for prevention of HIV seems only for the treatment of PrEP indication in men. Men population accounts for the vast cases of pre-exposure prophylaxis (PrEP). Further, women depend on whether the USFDA finds two external pharmacokinetic studies. Which are sufficient to generalize Descovy results.
Mr. Porges said that on Wednesday FDA’s advisory committee will grant an approval to launch Descovy for PrEP. Recently, Gilead Sciences, Inc. received approval of Truvada from FDA for PrEP. It is used for the treatment of patient suffering from are HIV-negative. It is estimated that two-thirds of Truvada’s will accounts for nearly US$ 3 billion sales. And could possess a threat to generic drug competition. Gilead claims that the data from DISCOVER and Truvada studies can be concluded. In order to show how Descovy would benefit adolescents and cisgender women at risk of getting HIV. According to the Centers for Disease Control and Prevention in 2017, estimates that nearly 19% of the approximately 38,739 new patients diagnosed with HIV were women. According to Cantor Fitzgerald, by the second quarter of 2019, around 213,000 HIV patients in the US were on Truvada therapy. According to the investment bank by 2025, estimates that Descovy sales will reach to about US$ 1.5 billion.