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FDA NEWS RELEASE

FOR IMMEDIATE RELEASE
P06-96
July 12, 2006

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FDA Approves the First Once-a-Day Three-Drug Combination Tablet for Treatment of HIV-1
Atripla is a Landmark Achievement of Three Cooperating Companies

The Food and Drug Administration (FDA) today announced approval of Atripla Tablets, a fixed-dose combination of three widely-used antiretroviral drugs, in a single tablet taken once a day, alone or in combination with other antiretroviral products for the treatment of HIV-1 infection in adults.

Atripla, the first one-pill, once-a-day product to treat HIV/AIDS, combines the active ingredients of Sustiva (efavirenz), Emtriva (emtricitabine) and Viread (tenofovir disoproxil fumarate). Bristol-Myers Squibb and Gilead Sciences have formed a joint venture to commercialize Atripla in the United States. The collaboration is the first of its kind in the field of HIV/AIDS. In certain territories, Merck holds the rights to efavirenz. All three companies will work together to ensure the product is available to patients and physicians. Atripla will be available for use in the United States as a new product approved under a new drug application (NDA). This would allow the drug to be considered for purchase for use in 15 other countries included under the President's Emergency Plan for AIDS Relief (PEPFAR). HIV-1 affects people worldwide.

Atripla was approved in under three months under FDA's fast track program. The manufacturer plans to make the drug available for purchase in the United States within 96 hours.

"This key breakthrough will help in our battle against HIV/AIDS -- not only in the U.S. but in other countries through the PEPFAR program. I commend those involved for working together to place this lifesaving drug on the fast track so it will be available more quickly to those who need it," said Mike Leavitt, Secretary of Health and Human Services.

The approval of Atripla comes as the result of an expedited review process outlined in a guidance by the FDA in May 2004. With today's approval, FDA will have approved seven co-packaged or fixed-dose combination products since the guidance was issued. For more information about the FDA's Expedited Review Process for HIV/AIDS Drugs, please go to: http://www.fda.gov/oc/initiatives/hiv/.

"Today's approval is a significant example of drug developers and FDA clearing the way to quickly deliver quality, life-saving HIV/AIDS drugs to people who desperately need them in the United States and abroad," said Andrew C. von Eschenbach, MD, Acting Commissioner of Food and Drugs. "Fixed dose combination products are an important tool in improving the quality of health care in developing nations. The approval of Atripla is a significant step forward in our commitment to providing medical care as effectively and efficiently as possible."

"The approval of Atripla simplifies the treatment regimen for HIV-1 infected adults, and will potentially improve the ability of patients to adhere to treatment resulting in long-term effective control of HIV-1. This offers a particularly important advantage for patients in many countries that are most affected by the AIDS epidemic and will also have a major impact in the U.S.," said Dr. Andrew C. von Eschenbach, the Acting Commissioner of Food and Drugs. "Atripla illustrates the outstanding achievements that are attainable when several pharmaceutical companies cooperate with our agency toward a common public health goal. I congratulate the three firms behind this unprecedented success -- and our reviewers, who worked with them every step of the way, on a job extremely well done."

"This new product offers a welcome option for prescribers who follow the recommended initiation of HIV-1 treatment with at least three highly active antiretroviral drugs, a regimen that has the potential to significantly improve the condition of many patients, and help them adhere to their regimen to help minimize the development of viral resistance," said Dr. Steven Galson, Director of FDA's Center for Drug Evaluation and Research. "Because all three components of Atripla have been in use for some time, their characteristics and effects are well known."

FDA approved Sustiva in 1998, Viread in 2001 and Emtriva in 2003. In addition, the safety and effectiveness of the combination of these three drugs were shown in a 48 week clinical study with 244 HIV-1 infected adults receiving the drugs contained in Atripla. In this trial, 80 percent of the participants achieved a marked reduction of the human immunodeficiency virus and a substantial increase in the number of healthy CD4 cells -- cells that fight against infection.

The labeling of Atripla includes a boxed warning that the drug's use can cause lactic acidosis (buildup of lactic acid in the blood). In patients with chronic Hepatitis B infection, the discontinuation of the treatment with Atripla (which is not approved for this use) can result in severe flare-ups of Hepatitis B infection. Other potential serious adverse events reported for the use of Atripla's ingredients include serious liver toxicity, renal impairment and severe depression. The most common adverse events experienced by participants in the combination trial included headache, dizziness, abdominal pain, nausea, vomiting and rash.

There are more than a million people living with HIV and AIDS in the United States today and 40,000 new cases are reported each year. Currently, there are 28 FDA approved products in the United States used in the treatment of HIV infection. FDA has played a strong role in addressing treatment and prevention from the beginning of the AIDS epidemic and has made significant contributions to the development of potent antiviral drugs that have dramatically helped people with HIV and AIDS live longer and healthier lives. Also within the last two years, FDA has approved more than 20 treatments to be used as part of President's Emergency Plan for AIDS Relief program, a $15 billion dollar initiative, which President Bush first announced in his 2003 State of the Union Address, to fight the international HIV/AIDS pandemic. PEPFAR is designed to prevent seven million new HIV infections, treat at least two million HIV-infected people, and care for ten million HIV-affected individuals, AIDS orphans and vulnerable children worldwide.

For more information, see http://www.fda.gov/cder/drug/infopage/atripla/default.htm and http://www.fda.gov/cder/drug/infopage/atripla/qa.htm.

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