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news.According to Pfizer and Sanofi-Aventis, the marketing partners of Exubera, an oral inhalation formulation of insulin, the FDA has extended its original review period for the drug by three months in order to review "additional technical chemistry data".
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In September, an FDA advisory committee recommended approval of Exubera for the treatment of adults with type 1 and type 2 diabetes. The FDA is not obligated to follow the advisory committee’s recommendation, but usually does so.
If approved Exubera would represent a major step forward in the delivery of insulin, and would be the first non-injectable insulin available since the discovery of the drug in the 1920s. Exubera is one of a handful of insulin products currently being developed, although it is the closest to market.
It is envisaged that inhaled insulin could one day supersede repeated insulin injections. Analysts have estimated worldwide sales could reach as much as $2 billion a year.
The companies say that they will continue to work closely with the FDA in their attempts to make the medicine available for patients.