BioCentury
ARTICLE | Clinical News

Stribild elvitegravir/cobicistat/emtricitabine/tenofovir disoproxil fumarate regulatory update

April 28, 2014 7:00 AM UTC

Gilead sent a petition for reconsideration to FDA asking the agency to reconsider a decision denying Gilead's request for 5 years of exclusivity for its HIV drug Stribild and for other fixed-dose combinations that have >=1 new active moiety. In February, FDA proposed to prospectively grant 5 years of exclusivity to fixed-dose combination products that have at least >=1 new active moiety. Currently, FDA interprets the 5-year new chemical entity (NCE) exclusivity provisions to mean that fixed-dose combinations that contain >=1 previously approved active moiety are eligible for only 3 years of exclusivity, even if the combination contains a new active moiety that alone would be eligible for 5 years of exclusivity. At the time, FDA also issued a decision denying a Citizen's Petition seeking 5 years of exclusivity for Stribild (see BioCentury, Jan. 28, 2013).

FDA decided not to recognize 5-year exclusivity for Stribild because at the time of the drug's approval the existing interpretation was in effect. The agency also said that applying the new interpretation to already-approved drugs would not advance the goal of the change, which was to encourage development of new drugs, and would burden sponsors with pending applications. In its petition, Gilead argued that the date of approval is not the relevant date for Stribild because FDA deferred its exclusivity determination until after it proposed the new interpretations. Gilead also argued that FDA's reasoning does not apply to Stribild because FDA has not accepted any ANDA or 505(b)(2) applications citing Stribild. ...