FDA approval for J&J HIV drug

Johnson & Johnson has been awarded an approval for the sale of its anti HIV drug, which will be introduced in the market under the trade name Intelence.

Intelence will be helpful for the patients who do not respond to other therapies. The main reason for the development of resistance by the HIV virus is that it can mutate itself to new forms which are not susceptible to the attack by drugs.

The drug also called Etravirine, belongs to a Non-nucleoside reverse transcriptase inhibitor family (NNRTI). It is effective as it blocks an enzyme which is required by the Human Immunodeficiency Virus to replicate and multiply in number.

Etravirine works by reducing the amount of HIV virus and also by increasing white blood cells, which are the main component of body’s immune defense against infections. It is also predicted that this drug might reduce the risk of death or infections that can occur with a weakened immune system.

Tibotec Therapeutics, a division of Ortho Biotech Products, L.P., a Johnson & Johnson company based in Bridgewater, N.J., which developed this drug had applied for a fast track review of the drug so that it can start marketing the drug at the earliest possible time. FDA takes the drugs for faster review in case of medications aimed at treating serious or life-threatening conditions.

"This is another significant new product for many HIV-infected patients who are NNRTI-resistant and whose infections are not responding to currently available medications," said Dr. Debra B. Birnkrant, Director of the FDA's Division of Antiviral Products.

The study was based on patients treated with a number 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 company has also applied for approval in Canada, Switzerland, Russia and Australia. Applications for approval have also been submitted to the European Agency.

The drug is approved for simultaneous use with the other drugs but it still has not been tested on pregnant women.

HIV infection is increasing at a fast rate and around 40 million people are infected with HIV.

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.