*EPF208 08/03/2004
U.S. Regulatory Agency Approves New AIDS Treatment Drugs
(Step could significantly simplify drug treatment regimen) (620)

By M. Charlene Porter
Washington File Staff Writer

Washington -- The U.S. Food and Drug Administration (FDA) has approved two new fixed-dose combination drugs to combat HIV infection. The drugs should help to simplify treatment regimens for people living with the virus, according to an August 2 FDA press release.

Epzicom, manufactured by GlaxoSmithKline, and Truvada, manufactured by Gilead Sciences Inc., both work by combining drugs from different classes. Researchers have found in their 20-year study of HIV that the most effective way to attack the virus is to use drugs that disable the microbe in different ways.

This multiple-drug treatment plan creates a complicated regimen the patient must follow, involving the administration of a number of pills on a particular schedule.

"Simplifying treatment regimens by reducing the number of pills and times per day patients need to take them provides significant public health benefits," said Dr. Lester M. Crawford, acting commissioner of the FDA, in an agency press release.

Simplified treatment is of special importance in nations where there are fewer health care practitioners to monitor the patients and coax them through the difficult regimen.

Crawford said approval of these combination drugs will increase the availability of medicines to those who need them. With FDA approval, Epzicom and Truvada now become suitable products for use in treatment programs sponsored under the President's Emergency Plan for AIDS Relief (PEPFAR). The $15 billion, five-year program aims to provide anti-retroviral drug treatment for 2 million people, in addition to care and assistance for people living with or affected by HIV/AIDS, and to expand AIDS prevention programs.

Since PEPFAR received its first congressionally authorized funding early this year, an additional 50,000 people living with HIV/AIDS in the program's 15 focus countries have begun to receive drug therapy, and U.S. government officials managing the program aim to boost those numbers rapidly.

The FDA has taken another step toward speeding the delivery of AIDS drugs to the hardest hit nations of the world with the initiation of a fast-track drug approval process. The agency has invited developing world pharmaceutical companies selling generic combination drugs in their regions to submit those medicines for an expedited FDA review.

"It is our firm belief that these steps will make a huge difference in the lives of people in Africa, Asia and the Caribbean, as well as the United States," Crawford said in a Washington speech.

Confronting health crises in their countries, developing world companies received patent waivers to copy and manufacture AIDS drugs invented by Western companies. If developing world companies submit their products for FDA review and if those so-called generic drugs receive FDA approval, then the United States will purchase them for expanding treatment under the PEPFAR program, officials say.

Critics have charged in the first few months of PEPFAR that the United States is not purchasing the cheaper generic drugs -- roughly one fifth the cost of brand-name drugs -- in order to direct its dollars only to Western pharmaceutical companies. U.S. Global AIDS Ambassador Randall Tobias dismisses the criticism saying the he wants consumers in other countries to benefit from the same tough regulatory scrutiny that protects American consumers from inferior products.

"We should not have two standards ... a standard of ����good' in the Western world and ����good enough' elsewhere. It ought to be the same standard," Tobias said at a briefing last month held at the XV International AIDS Conference in Bangkok, Thailand.

Ranbaxy Laborators Ltd. announced in late July that it will seek FDA approval for its combination AIDS drugs. The company, based in New Delhi, India, supplies AIDS drugs to about 40 countries

(The Washington File is a product of the Bureau of International Information Programs, U.S. Department of State. Web site: http://usinfo.state.gov)

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