FDA Approves First Single Tablet for HIV

Bristol-Myers Squibb and Gilead Sciences received approval from the FDA for Atripla for the treatment of HIV-1 infection in adults. Atripla is the first-ever once-daily single tablet regimen (STR) for HIV intended as a stand-alone therapy or in combination with other antiretrovirals. The product combines Sustiva, manufactured by BMS, and Truvada, manufactured by Gilead Sciences. In December 2004 the two companies established a joint venture to develop and commercialize the STR.

Truvada is a fixed-dose product that contains two of Gilead’s anti-HIV medications, Viread and Emtriva, in a once-daily tablet for use as part of combination therapy. Atripla will be available in the U.S. shortly.

“We appreciate the recognition by the FDA of this important therapeutic advance, and with their approval of Atripla in just over two months, patients will now have rapid access to the first once-daily single tablet regimen for the treatment of HIV-1 infection in adults,” said John C. Martin, Ph.D., president and chief executive officer of Gilead Sciences. “We are proud to have worked closely with Bristol-Myers Squibb in this precedent-setting collaboration to simplify therapy for physicians and patients.”

“With the approval of Atripla, Bristol-Myers Squibb continues two decades of progress in the development and commercialization of medications to treat HIV. Partnering with Gilead, we are able to address another area of need for adults infected with HIV-1,” said Anthony C. Hooper, president, U.S. Pharmaceuticals, BMS. “Atripla is an important step forward as we continue our focus on discovering, developing and providing innovative treatments for serious diseases.”

The once-daily STR contains three medicines from two classes of anti-HIV drugs. Atripla contains 600 mg of efavirenz, a non-nucleoside reverse transcriptase inhibitor (NNRTI), 200 mg of emtricitabine and 300 mg of tenofovir disoproxil fumarate, both nucleoside reverse transcriptase inhibitors (NRTIs). All three active ingredients work by blocking reverse transcriptase, an enzyme necessary for HIV replication.