Exubera Inhaled Insulin Gets Favorable Committee Review In Europe
This article was originally published in The Pink Sheet Daily
Executive Summary
European Medicines Agency's Committee for Medicinal Products for Human Use recommends approval of Pfizer/Sanofi's agent for type 1 and 2 diabetes with post-market monitoring for pulmonary function decline and hypoglycemia.
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The European Medicines Agency's Committee for Medicinal Products for Human Use is recommending approval of Pfizer/Sanofi-Aventis' inhaled insulin Exubera for type 1 and 2 diabetes. "The CHMP, on the basis of quality, safety and efficacy data submitted, considers that there is a favorable benefit-risk balance for Exubera in the approved indications and therefore recommends the granting of marketing authorization," an Oct. 13 committee "summary of opinion" states. The CHMP opinion follows a favorable review of the product by FDA's Endocrinologic & Metabolic Drugs Advisory Committee in September (1 (Also see "Pfizer/Sanofi Exubera Effective For Both Type 1 And Type 2 Diabetes, Committee Says" - Pink Sheet, 8 Sep, 2005.)). The committee notes that "the most commonly observed side effects are hypoglycemia and cough" and that these events would be monitored after Exubera received market authorization. "A pharmacovigilance plan and risk minimization activities will be performed to address identified or potential risks, in particular pulmonary function decline and hypoglycemia," the committee summary states. EMEA review of the Exubera marketing application filed by Pfizer and partner Aventis (now Sanofi-Aventis) began on Feb. 23, 2004 (2 (Also see "Pfizer/Aventis File For Exubera In Europe; No Timeline Yet On U.S. Submission" - Pink Sheet, 4 Mar, 2004.)). "Pending approval of the European Commission, Exubera would represent a major advance in insulin delivery and would be the first non-injectable insulin available in Europe," Pfizer said. The companies are seeking U.S. and European approval for use in combination with a longer-acting subcutaneous insulin for the treatment of adults with type 1 diabetes, and for treatment of adults with type 2 diabetes not adequately controlled with oral antidiabetic agents. Pfizer is not speculating on a timeline for approval of Exubera in the EU. The user fee date for the U.S. application is Oct. 27. - Elizabeth Walker |