Bristol-Myers Seen Winning Panel's Backing for HIV Drug
May 13, 2003
Bristol-Myers Squibb Co. today will probably win the backing of a government advisory panel for a new HIV treatment after getting favorable comments from reviewers, analysts said. U.S. Food and Drug Administration analyses "support the applicant's findings" on safety and efficacy, agency staff said in a review posted on the regulator's Web site Monday. The FDA created the report to prepare committee members to discuss Bristol-Myers' experimental medication atazanavir.Adapted from:
Atazanavir's once-daily dosing makes it more convenient than rival protease inhibitors, which include Abbott Laboratories' Kaletra. Ease of use "is a big advantage for the drug," said Philippe Chiliade, medical director of Washington's Whitman-Walker AIDS Clinic. "It will probably be used most of the time as a front-line drug, as a first potential regimen," Chiliade said.
The FDA staff asked the committee tomorrow to consider atazanavir's potential risks to the heart and liver. "Safety issues appeared manageable," in the FDA review, Thomas Weisel Partners analyst Girish Tyagi said in a report about the agency's preview documents. He and analyst Scott Kay of Banc of America Securities LLC predicted a favorable panel decision based on staff comments. Bristol-Myers is already the biggest U.S. maker of AIDS drugs; it produces Sustiva, Videx and Zerit.
Bristol-Myers' research found atazanavir less likely to change the level of some fats circulating in patients' blood -- a complication of some therapies that often forces patients to take other drugs to lower their risk of heart disease. Atazanavir "produced less change in total cholesterol [and] triglycerides than all comparators," the FDA reviewers wrote. "These differences were found to be statistically significant."
Bristol-Myers applied for U.S. approval of atazanavir in December. The FDA agreed to try and complete its review in six months, instead of the customary 10 months, because of the need for new medicines to fight HIV.
05.13.03; Bloomberg News
This article was provided by CDC National Prevention Information Network. It is a part of the publication CDC HIV/Hepatitis/STD/TB Prevention News Update.