Last week, development-stage biotech Neurochem (NASDAQ:NRMX) got word from the FDA that a regulatory decision for its lead drug, Kiacta, would be delayed by up to three months.
Kiacta is a drug candidate developed to treat a rare condition, Amyloid A amyloidosis, a disease that is associated with chronic inflammatory diseases and infections. Neurochem first filed a New Drug Application for Kiacta in February 2006, and in August the FDA issued an approvable letter with a request for more efficacy data.
The FDA has been delaying PDUFA dates and approvable letter responses at what seems like a high rate in the past six months. This latest extension of the review period for Neurochem's approvable letter response, though, is a result of new data submitted two months ago from a previously completed study with Kiacta.
The newly pushed-back date for a marketing thumbs up or down from the FDA is now August 16 of this year. The European Union medical authorities are also expected to issue a decision on the drug in the second half of the year.
The main support for the Kiacta marketing application with the FDA was a phase 2/3 study that produced data from 183 patients (including study dropouts). The dearth of clinical trial data will make it very difficult for Kiacta to gain approval. Unfortunately for Neurochem, Kiacta failed on its primary endpoint in this study.
If the FDA already bumped Kiacta once and requested another clinical trial with the drug, then submitting an approvable letter response without data from a new study doesn't bode well for Kiacta's odds of getting to market in the next three months.
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Fool contributor Brian Lawler does not own shares of any company mentioned in this article. The Fool has a disclosure policy.
