Gilead Sciences, Inc. (GILD) announced that it has submitted a New Drug Application (NDA) to the FDA for its tenofovir alafenamide (TAF)-based single tablet regimen (STR) for the treatment of adults suffering from HIV-1 infection. The once-daily combination drug comprises TAF 10 mg, Vitekta (elvitegravir) 150 mg, Tybost (cobicistat)150 mg and Emtriva 200 mg (emtricitabine).
Gilead plans to submit a regulatory application for this combination regimen in the EU by the end of this year.
The company submitted the NDA based on encouraging 48-week data from two pivotal phase III studies. Results from the randomized, double-blind studies revealed that the once-daily TAF-based combination drug was non-inferior to Gilead’s highly successful HIV treatment Stribild in reducing HIV levels at 48 weeks, thereby meeting the primary efficacy endpoint (proportion of patients with viral load less than 50 copies/mL). Moreover, the TAF-based regimen demonstrated favorable renal and bone safety measures compared to Stribild.
We note that earlier this year, the FDA cleared two of Gilead’s HIV drugs — Tybost and Vitekta (read more: Gilead's HIV Drugs Tybost and Vitekta Get FDA Clearance).
Meanwhile, Johnson & Johnson (JNJ) has announced that the FDA has approved its hepatitis C virus (HCV) drug Olysio in combination with Gilead’s sofosbuvir as an all-oral, interferon- and ribavirin-free treatment for genotype 1 chronic hepatitis C infection in adults.
Gilead sports a Zacks Rank #1 (Strong Buy). Equally well-ranked stocks in the health care space include Allergan (AGN) and AbbVie (ABBV).
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