An expert panel will meet today to consider whether Pfizer's new inhaled insulin, Exubera, should be given marketing approval. Analysts view Exubera as a test case for how stringent the FDA will be on safety issues in a post-Vioxx regulatory world. Trials of Exubera showed a slight drop in patients' breathing abilities, raising safety concerns about the new drug. Another concern about the drug is that patients have only been studied for two years after beginning treatment, raising fears that there could be unknown long-term health consequences.
For its part, Pfizer is promising to actively orchestrate a vigorous, post-approval study of patients to track any possible negative effect that could occur. Developed by Nektar Therapeutics in San Carlos, California, Exubera is the first of a new class of inhaled insulins to reach an expert panel review. By reducing the need for injections, Pfizer says that the drug presents a major breakthrough in administering effective treatment.
- read this report from the Los Angeles Times for more
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