FDA Warns Doctors On J&J's HIV Drug Prezista

(RTTNews) - U.S. Food and Drug Administration, or FDA, warned healthcare providers on Friday about a possible link between a Johnson & Johnson's (JNJ | news | PowerRating | PR Charts ) HIV drug Prezista and hepatotoxicity, or chemical-driven liver damage.

In a posting on its website, the agency said it has received reports of drug-induced hepatitis in patients taking J&J's Prezista. Prezista is a protease inhibitor that is used in combination with another HIV drug ritonavir.

FDA noted that though causality is not firmly established, it suspects an association between Prezista and hepatotoxicity. Tibotec Pharmaceuticals, Ltd, a subsidiary of J&J, manufactures Prezista.

In general, HIV antiretroviral medications are associated with liver enzyme elevations, however, for some medications, an association with hepatotoxicity is more firmly established.

Earlier this month, J&J and FDA added new warnings to Prezista's label, indicating that 0.5% of patients in the original trials of the drug showed hepatitis.

FDA approved Prezista, a protease inhibitor, in 2006 for use in highly treatment-experienced HIV patients. Prezista is in competition with Boehringer Ingelheim's Aptivus in this patient subgroup, and, as a result, Tibotec aims to achieve approval for the drug in earlier lines of HIV treatment to expand market opportunity. In January, the FDA has granted accelerated approval to Tibotec Pharma's anti-HIV medication INTELENCE (etravirine) tablets.

However, it is expected that the warnings would only cause limited harm to Prezista's overall future performance as the hepatic adverse events were mostly observed in treatment-experienced patients with co-existing liver disease and could not be clearly linked to Prezista, since patients received multiple drugs at a time.

Still, the warning issued by Tibotec and the FDA has highlighted a significant issue with all Protease inhibitors, or PIs. PIs are considered as a cornerstone in antiretroviral therapy, and generated total sales of $3 billion in 2007 across the US and other European countries, according to IMS. The market leaders in this class are Abbott's (ABT | news | PowerRating | PR Charts ) Kaletra and Bristol-Myers Squibb's (BMY | news | PowerRating | PR Charts ) Reyataz. Indeed, toxicity is a general problem associated with the PI class.

Prezista's direct competitor Aptivus carries a boxed warning for hepatotoxicity and intracranial hemorrhage, while Kaletra is associated with dyslipidemias, gastrointestinal adverse effects and hyperbilirubinemia.

It is expected that the HIV market could worth over $11 billion in 2016. In the next 10 years patent expiries and new product launches are expected to bring significant changes to the HIV market.

J&J, a New Brunswick, New Jersey-based Dow component, ended Friday's regular trading up by 50 cents at $65.38. In the extended trading, the stock lost 25 cents to settle at $65.13.

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