October 22, 2008 / 2:51 PM / 11 years ago

US FDA expands approval for J&J HIV drug

(New throughout)

WASHINGTON, Oct 22 (Reuters) - U.S. health regulators have expanded approval for Johnson & Johnson’s (JNJ.N) Prezista in combination with other drugs to treat HIV patients who are just beginning to take medication for the virus, the company said on Wednesday.

Prezista, or darunavir, had already been approved for use along with other HIV drugs in patients who were already taking protease inhibitors but had developed resistance.

Patients new to HIV therapy should take the drug with ritonavir and food to get the best results, the company said. Ritonavir, sold by Abbott Laboratories (ABT.N) under the name Norvir, helps boost the concentration of Prezista in the body by slowing its breakdown.

The approval offers another option to treat the human immunodeficiency virus, or HIV, the company said in statement. Protease inhibitors help prevent the AIDS-causing virus from replicating.

Common side effects include diarrhea, nausea, headache and serious skin rashes, the FDA has said. Reports of hepatitis and liver failure have also been found in Prezista patients, the company said.

Johnson & Johnson also said the FDA finalized its approval of the drug for patients used to taking HIV medications. When the FDA cleared the use in 2006 it required follow-up studies to verify its benefits.

The agency said on Wednesday the company’s additional studies supported Prezista, the company said.

First-time HIV drug patients should take two 400-milligram tablets once a day. Those who have been on medication before should still take 600-milligrams. The drugmaker added it was discontinuing its 300-milligram tablet since it began manufacturing a 600-milligram version earlier this year.

The drug is marketed in the United States by Tibotec Therapeutics, part of Johnson & Johnson’s division of Ortho Biotech Products.

Shares of Johnson & Johnson were off 2.6 percent, or $1.64 at $62.02 in morning trade on the New York Stock Exchange. (Editing by Dave Zimmerman)

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