Food and Drug Administration regulators turned down a request from Johnson & Johnson to expand the approved uses for Risperdal, a treatment for bipolar disorder. J&J received a not approvable letter from the FDA to use Risperdal in Alzheimer’s-related psychoses.

This is after last weeks announcement that the FDA rejected J&J’s application to market Risperdal for patients with autism after it petitioned for an additional use of the drug.

It seems the FDA is taking a slow and cautious route on new approvals, especially after the Vioxx withdrawal, as we noted before. In April, the FDA ordered new warnings on all antipsychotic drugs, including Risperdal, to alert physicians to a higher death rate when the medicines are prescribed for the atypical use of treating dementia in elderly patients.

Things are not all bad for J&J, though. It announced that it plans to file and receive marketing approval for 10 to 13 new drug compounds by 2007. J&J said that it expects to grow even though it will likely lose patent protection on some of its top-selling drugs. Obviously, this is geared to rev up confidence in the company. J&J, like lots of big pharmas these days, is staring down the barrel of a growing number of patent expirations.

The company expects new growth would come from therapies to treat cancer; viruses such as HIV; urology treatments, including a drug for premature ejaculation; and antibacterials to treat serious infections. J&J said it could have as many as 70 product filings between 2005 and 2011, including 23 new drug compounds and 47 line extensions.

Interestingly, the company said it is rapidly expanding its research into drugs based on biotechnology, or live organisms. While this brings great potential, this will certainly not be without risks. Earlier, when two patients taking Tysabri, a new drug for multiple sclerosis, developed a rare brain disease, the $3 billion a year in potential profits suddenly vaporized. Shares of Biogen Idec fell by nearly half, and Elan, trading at $30, took a sickening swan dive to $4.

It’s an exciting time but biotechnology’s risks will make for some stomach-churning thrills.

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One Comment

  1. FDA Rebuffs New Risperdal Use

    The FDA has got conservative since the Vioxx debacle….