FDAnews Drug Daily Bulletin

EXUBERA REVIEW PERIOD EXTENDED BY THREE MONTHS

Nov. 8, 2005
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The FDA has extended the review period for Pfizer and sanofi-aventis’ potential breakthrough diabetes drug Exubera to review additional technical chemistry data submitted by the sponsors.

Pfizer and sanofi-aventis had expected a decision from the FDA this week, but the agency recently informed them that it was delaying the user fee date by three months to analyze the additional chemistry information. The companies are seeking approval of Exubera (inhaled powder insulin) as a treatment for Type 1 and 2 diabetes.

Exubera is a potential blockbuster drug that, if approved, would be the first inhaled insulin powder available on the U.S. market. The product, which is self-administered using an inhaler, is highly anticipated by diabetics, many of whom want an alternative to insulin injections, the current standard of treatment.