Combination AIDS Drugs Moving Through FDA's Approval Process
Cipla
Personal Health
By Sarah Lueck and David P. Hamilton
370 words
3 August 2004
The Wall Street Journal
D4
English
(Copyright (c) 2004, Dow Jones & Company, Inc.)
Indian drug maker Ranbaxy Laboratories Ltd. said it will apply for speedy
approval from the Food and Drug Administration for its generic combination AIDS
drug, raising the possibility that a U.S. global AIDS-treatment program might be
able to distribute the product by next year.
Meanwhile, the FDA approved two other combination AIDS medications: Truvada by
Gilead Sciences Inc. and Epzicom by GlaxoSmithKline PLC. Both Truvada and
Epzicom are single pills containing two existing AIDS drugs. Most patients will
still need to take a third drug to effectively control the AIDS virus, although
Gilead is working with Bristol-Myers Squibb Co. and Merck & Co. to develop such
a three-in-one pill.
The Ranbaxy drug, which is unlikely to be sold in the U.S. because of patent
restrictions, combines generic versions of three brand-name AIDS medications. It
is intended largely for developing nations.
Ranbaxy said it will submit its application to the FDA before the end of the
year. AIDS-treatment groups have been pushing for wider access to the pill for
developing countries because it is cheaper than its brand-name components and
easier for patients to use. Advocates have pressured the U.S. to allow its
multibillion AIDS fund to purchase such three-in-one pills.
But the Bush administration, echoing arguments made by the pharmaceutical
industry, said makers of generic AIDS drugs should prove to the FDA that their
drugs are safe and high-quality before the U.S. AIDS fund will purchase them. So
far, the FDA hasn't reviewed the Ranbaxy drug due to patent restrictions that
would prevent it from being sold in the U.S.
Under an expedited approval process that the FDA announced in May, the agency
has said it will approve drugs for use globally even if they are protected by
U.S. patents. Once an application is complete, the FDA has promised a review of
four to six weeks.
FDA Commissioner Lester Crawford said the agency had "gained important
scientific knowledge" while reviewing the Gilead and Glaxo drugs that would be
"useful" as the agency reviews other combinations.
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