Once-rejected drugs in Gilead's Stribild get FDA nod to go it alone

Gilead ($GILD) has been seeking FDA approval for HIV drugs Tybost and Vitekta for a while now, but the agency dealt the drugmaker a setback with Complete Response Letter last year. Now, 17 months later, the two have passed muster.

Last week, U.S. regulators green-lighted the meds, which are already packaged with emtricitabine and tenofovir in Gilead's four-in-one HIV-fighter Stribild. The solo approvals will offer patients more flexibility--and afford Gilead the opportunity to hawk its drugs in combination with those from rival pharmas.

Gilead's been waiting for that opportunity since back in June 2012, when it filed for FDA approval. But in April 2013, the agency said it couldn't approve the applications in their current forms, citing deficiencies in documentation and in validation of some quality testing procedures.

Now that the company has addressed the agency's concerns, it can roll the drugs out on their own. And while they may not match the launch of Stribild--that drug hauled in $57.5 million in 2012 after launching in August--they'll reach some HIV-1 patients on their competitors' drugs.

Vitekta, for one, can now be taken at an 85-mg dose as well as the 150-mg dose available in Stribild, and it can now be used along with AbbVie's blockbuster ($ABBV) Norvir and other antiretrovirals. And with its thumbs up, Tybost can now be used as a booster for cocktails that include Bristol-Myers Squibb's ($BMY) Reyataz or Janssen's Prezista, the FDA said.

- see the NDA approvals here and here (PDF)

Special Report: Top 15 Drug Launch Superstars - Stribild - Gilead Sciences

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