Schering-Plough (NYSE: SGP ) could use a little pick-me-up after the disastrous start of the year it and Merck (NYSE: MRK ) had with the release of their cholesterol drugs' post-marketing clinical trial data.
Schering could get a boost tomorrow when an FDA panel meets to review Bridion, its drug used to reverse the effects of anesthesia. Schering acquired the drug when it purchased Akzo Nobel's (Nasdaq: AKZOY ) human- and animal-health-care subsidiary, Organon BioSciences. Bridion would compete against other reversal agents sold by generic-drug makers like Baxter (NYSE: BAX ) and Hospira (NYSE: HSP ) .
For the most part, the FDA document given to the panel members seemed pretty positive; still, reviewers did have a few concerns.
The main issue seems to be whether the drug can be used in emergency situations where doctors might want to revive a patient quickly. The FDA report seems a little unsure if the endpoint used to measure whether the patient had woken up has "clinical relevance." While the FDA questioning an endpoint this late in the game is never a good sign, it appears that Schering can probably get approved for non-emergency situations even if the panel isn't gung-ho about the data from the trial testing the drug in mock emergency situations.
There are also two safety issues that the FDA has questions about. The first revolves around the fact that the drug sticks to bones and affects the growth of tooth enamel in young rats, leading the FDA to wonder if the drug should be used in children. The second concern is about hypersensitivity in a subset of patients. Some of the safety data is still outstanding, so the committee may not be able to answer these questions.
While there may be some hiccups for Schering during tomorrow's meeting, the chance of FDA approval looks pretty good, especially when executive summaries contain statements like this, "Our current assessment is not in substantial disagreement with [Schering] regarding the data or the findings contained in this application." For Schering, that pep talk could be just what the doctor ordered.
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