FDA Approves New Gilead HIV Drug

Gilead new drug is likely to grab the revenue in billions.

On Monday, Gilead Sciences got the approval from the FDA for Descovy – its third TAF-based combination HIV Therapy. The potential drug could be used to treat 12 year or more years aged HIV patients. After the declaration of the news, Gilead’s stock jumped up 0.93% and reached $95 during mid-day trading. Analysts are optimistic that the drug will prove to be a blockbuster garnering high amount of profits for the company.

The newly approved drug is also expected to get green signal from the European regulators, which is likely to boost the growth of the drug. The European Medicines Agency, CHMP, has already given a positive response for Descovy’s use against HIV.

The approval of the drug is the stepping stone for the company to smoothly transition its HIV product line to TAF (tenofovir alafenamide) from TDF (tenofovir disoproxil fumarate). The new drug is likely to improve Gilead’s existing HIV bestseller Viread because its key ingredient ‘tenofovir’ is a newer formulation.

Earlier, the company pointed out the advantage of TAF by saying, “Data shows that because TAF enters cells, including HIV-infected cells, more efficiently than TDF, it can be given at a lower dose and there is 91% less tenofovir in the bloodstream.” Additionally, the drug can be given to the patients at lower doses, which will eradicate the likelihood of future negative side effects.

According to the analysts, the blockbuster drug is likely to generate around $1 billion worth sales and at its summit; it is likely to touch the threshold of $2 billion.

The spokesperson from Gilead titled the therapy as “the first new HIV treatment backbone,” which is permitted in more than ten years. According to Norbert Bischofberger, the company’s Chief Scientific Officer, the new drug highlights an upcoming significant evolution in HIV care. He added, “As part of a single tablet regimen or partnered with a third agent, the components of Descovy offer patients a simple and effective combination with a safety profile that has the potential to improve health.”

The Californian biotech titan has recently bagged a whole series of new HIV approvals, including Odefsey and Genvova. However, patient advocates have subjected some of the drugs to severe criticism. Last fall, Gilead’s Genvova’s approval was met with criticism when AIDS Healthcare Foundation accused it to be an effort by the biotech giant to immortalize its older HIV med Stribilid’s patents due to the reason that the both drugs were substantially similar except for the newer formulation of tenofovir in Genvova.

The TAF basically increased the efficacy of the new drug and it is likely to had improve the antiviral efficiency of Genvova earlier too. Apart from the potential profits which Gilead’s HIV/AIDS therapies will bring in for the company, the biotech’s blockbuster Sovaldi and Harvoni – the drugs for hepatitis C treatment – garnered around $30 billion in 2015 in the sales across the globe.