APPROVAL RECOMMENDED FOR EXUBERA
Pfizer and sanofi-aventis recently received more positive news on their highly anticipated inhaled insulin drug Exubera when a European Medicines Agency (EMEA) advisory committee recommended approval of the product for Type 1 and 2 diabetes.
EMEA's Committee for Medicinal Products for Human Use (CHMP) concluded that "on the basis of quality, safety and efficacy data submitted, there is a favorable benefit-risk balance for Exubera (inhaled powder insulin) in the approved indications and therefore [the CHMP] recommends the granting of the marketing authorization," a recent meeting summary states.
The CHMP's recommendation comes roughly one month after the FDA's Endocrinologic and Metabolic Drugs Advisory Committee voted 7-2 to recommend approval for Exubera. The FDA advisers expressed a variety of concerns about Exubera, but ultimately concluded that the drug's benefits outweigh its risks.
The CHMP also raised safety concerns during its recent meeting, noting that Exubera has been known to cause hypoglycemia and cough. To address these safety issues, the CHMP recommended that "risk minimization activities be performed to address identified or potential risks, in particular pulmonary function decline and hypoglycemia."
Developed jointly by Pfizer and sanofi-aventis, Exubera is a potential blockbuster drug that, if approved, would be the first inhaled insulin powder available in the U.S. and European Union markets. 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.