January 19, 2008 / 4:14 AM / 12 years ago

FDA clears new Johnson & Johnson HIV drug

WASHINGTON (Reuters) - Health-care products maker Johnson & Johnson (JNJ.N) won U.S. approval to sell a new HIV drug called Intelence for patients with resistance to other therapies, U.S. officials said on Friday.

An AIDS patient holds his morning dose of medication at the AIDS hospice in the Wat Phrabaht Nampu temple in Thailand's Lop Buri province, about 160 km (100 miles) north of Bangkok, July 3, 2004. REUTERS/Adrees Latif

The drug, also known as TMC125 or etravirine, is a new member of the family of AIDS-fighting drugs called non-nucleoside reverse transcriptase inhibitors (NNRTI).

More than two dozen drugs are approved for fighting the deadly HIV virus. Patients need new options because HIV can mutate to resist existing treatments.

The Food and Drug Administration said it approved Intelence for use with other AIDS drugs. It was cleared for adults who have failed alternative HIV therapies.

The new tablet is the first NNRTI to work for patients who have developed resistance to medicines in the same family, officials with J&J unit Tibotec said.

“Doctors and patients can use (Intelence) in those patients that ... have had several or multiple rounds of resistance develop,” Tibotec Research and Development President Roger Pomerantz said in an interview.

Tens of thousands of patients worldwide have resistance to NNRTIs and could be candidates for Intelence, Pomerantz said.

The drug’s wholesale cost will be $5.45 per tablet, Tibotec spokeswoman Pamela Van Houten said. The approved dosing is two tablets twice per day, or a total of four tablets daily.

Close to 40 million people are infected with HIV.

Medicines in different classes attack the virus at various stages in its cycle of infection and replication. NNRTIs block a key enzyme that HIV uses to replicate.

AIDS drugs do not cure the infection but they can suppress the virus and minimize symptoms.

The approval of Intelence was based on studies of patients treated with a cocktail of AIDS drugs plus Intelence or a placebo for 24 weeks. Sixty percent of patients treated with Intelence had their virus suppressed to undetectable levels, compared with 40 percent of placebo patients, Tibotec said.

The most common problems reported were skin rashes and nausea, the FDA said. The agency advised patients who take Intelence to contact a doctor if a rash develops. Rare cases of serious skin rashes such as Stevens-Johnson syndrome were reported in studies, the FDA said.

The agency also cautioned that Intelence patients may develop infections, and long-term effects are unknown.

The drug may interact with various medications and patients should tell their doctors and pharmacists about all medications they take, the FDA SAID.

Reporting by Lisa Richwine and Michael Flaherty; Editing by Bill Trott

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