Exubera Approved In Europe One Day Before U.S. User Fee Date
This article was originally published in The Pink Sheet Daily
Executive Summary
Pfizer said it is investing in "extensive educational programs" to respond to concerns about the inhaled insulin's dosing mechanism.
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Pfizer's Exubera inhaled insulin therapy was approved by the European Commission Jan. 26, one day ahead of its user fee date in the U.S. The EC approved Exubera for the treatment of adult patients with type 1 diabetes mellitus in addition to long-acting injectable insulin "for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns," Pfizer said. Exubera is also indicated for the treatment of type 2 diabetes not adequately controlled with oral anti-diabetic drugs. At an October meeting, the European Medicines Agency's Committee for Medicinal Products for Human Use recommended granting marketing authorization to Exubera (1 (Also see "Exubera Inhaled Insulin Gets Favorable Committee Review In Europe" - Pink Sheet, 13 Oct, 2005.)). In the weeks leading up to Exubera's Jan. 27 user fee date in the U.S., Pfizer has projected a great deal of confidence that it will garner U.S. approval for its novel inhaled insulin therapy. On Jan. 12, Pfizer announced it had acquired Exubera marketing rights from partner Sanofi-Aventis for $1.3 bil. (2 (Also see "Pfizer Banking On Exubera Approval" - Pink Sheet, 13 Jan, 2006.)). The transaction gave Pfizer - which co-developed the insulin with Sanofi and Nektar - full rights to the product. According to Pfizer, the firm's R&D investment in Exubera "now stands over $1 bil." The firm is touting Exubera as a fast-acting, dry powder insulin formulation that is inhaled into the lungs using "a simple-to-use, hand-held device that does not require batteries or electricity." "The device, which weighs four ounces and is about the size of a carrying case for a pair of eye glasses, is designed to deliver an accurate and precise dose of insulin each time it is used," Pfizer said. Pfizer did not bring an example of Exubera's novel inhaler to the drug's review by FDA's Endocrinologic & Metabolic Drugs Advisory Committee. The committee recommended approval of Exubera in September, but expressed concern regarding the inhaler's unwieldy size and dosing mechanism and urged an extensive physician and patient educational campaign (3 (Also see "Pfizer/Sanofi Exubera Effective For Both Type 1 And Type 2 Diabetes, Committee Says" - Pink Sheet, 8 Sep, 2005.)). Following the announcement of Exubera's EU approval, Pfizer said it is "investing in extensive educational programs to support healthcare professionals and patients." During its review, FDA's advisory committee also expressed concern regarding Exubera's safety in patients with underlying lung disease. Pfizer said that patients "should not take Exubera if they have poorly controlled or unstable lung disease, or if they smoke or have stopped smoking less than six months prior to starting Exubera treatment. If a patient starts smoking or resumes smoking, he or she must stop using Exubera and see a healthcare provider about a different treatment." The company will recommend patients undergo a physician-administered lung function test prior to starting Exubera therapy. While patients may see a "small decrease" in lung function within the first months of Exubera treatment, the symptoms "should not worsen as treatment is continued," Pfizer said. In clinical trials, patients reported "a mild cough" within seconds or minutes immediately after inhaling insulin that diminished with continued Exubera use, the company said. -Turna Ray |