FDA clears Atripla, a combination treatment for AIDS patients.
Experts say the new pill, called Atripla and combining Bristol-Myers Squibb Co.'s Sustiva and Gilead Sciences Inc.'s Truvada (a combination of the company's Viread and Emtriva), will dramatically help AIDS patients comply with their medication regimens.
The failure of patients to take their drugs faithfully, they note, is a big problem for those suffering from disease because it allows HIV to develop resistance to the drugs. Missing even 8% of doses can lead to the growth of a drug-resistant version of the virus.
"It makes the burden of taking pills much less than having to take them multiple times a day," Dr. Anthony Fauci, an immunologist and director of the National Institutes of Health's Infectious Disease Institute, recently told ABC News.
Just a decade ago AIDS patients were forced to take as many as two or three dozen pills a day.
Most of the patients now taking Sustiva and Truvada separately are expected to switch to the new pill. But for those taking other drug combinations, the new pill may not work. The HIV virus in many of these people is already resistant to one of the drugs in the new pill, while others simply cannot tolerate the side effects that can come from either Sustiva or Truvada.
While the single pill is good news for the nearly 1 million Americans living with AIDS, Fauci notes that most of the 40 million people with the disease around the world will not be able to access the medication easily.
Still, he says, the single pill will be priced the same as the separate drugs, and Bristol-Myers Squibb and Gilead have agreed to make the new pill available to developing nations at a reduced cost.
The approval of the once-a-day, single-pill AIDS treatment is the second time in two months that the FDA has given its O.K. to a one-pill AIDS drug.
In June the agency approved a twice-a-day pill developed by Aurobindo Pharma in Hyderabad, India. The pill contains three drugs--GlaxoSmithKline PLC's Epivar (lamivudine) and Retrovir (zidovudine) and Boehringer Ingelheim Ltd.'s Viramune (nevirapine)--that are considered to be front-line therapies for AIDS and account for nearly half of the drugs taken by patients with the disease.
Because there are established patents on the individual components of the twice-a-day pill, it cannot be sold in the United States. But 15 countries around the world will get the drug as part of the federal government's $15 billion AIDS relief program.
While the FDA had until October to decide on the fate of the once-aday AIDS pill, the agency was not expected to take that long to act because the government has been encouraging companies to collaborate on finding easier ways to treat AIDS.
While the possibility of a oncedaily treatment emerged a few years ago with the development of individual drugs that needed to be taken only once a day, no single company controlled all the drugs needed for an effective combination. But as drug company executives began searching for ways to grow their sales, they started to approach rivals to talk about collaborative efforts.
Such was the case of Bristol-Myers, which was looking to increase sales of Sustiva. In 2003 the company approached Gilead, which already had two once-a-day pills, about the possibility of creating a single pill for AIDS patients.
In April 2004 the FDA summoned the two companies and Merck & Co. to a meeting in Washington, D.C., and asked them if they would be willing to work together to develop simpler pills as part of the president's plan to provide antiviral treatments to poor countries. A month later the three drug makers announced their plan to develop a new AIDS pill.
Merck, which markets efavirenz (the chemical name for Sustiva) in many developing nations, is expected to play a role in marketing the new drug in these countries.
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|Title Annotation:||RX/BRANDED DRUGS; Food and Drug Administration|
|Publication:||Chain Drug Review|
|Date:||Jul 24, 2006|
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