Novartis’ Foradil Certihaler Approved For Asthma
This article was originally published in The Pink Sheet Daily
Executive Summary
FDA approval of asthma treatment follows receipt of two “approvable” letters.
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FDA approved Novartis' Foradil Certihaler (formoterol fumarate inhalation powder), a new formoterol formulation for the treatment of asthma, Dec. 15, according to the agency. The drug is indicated for "the long-term, twice daily (morning and evening) administration in the maintenance treatment of asthma and in the prevention of bronchospasm in adults and children five years of age and older with reversible obstructive airway disease." Novartis licenses the dry-powder technology for the Certihaler from U.K. -based SkyePharma, which will receive royalties from worldwide sale of the drug. The approval follows two FDA "approvable" letters for the product, the first in 2003 and the second in April. The second letter related to a recall of the product in Germany and Switzerland over concerns that accidental mishandling of the device could cause inaccurate dosing, according to SkyePharma. However, "the device was modified, and the modifications were submitted to FDA," the company said. Foradil Certihaler delivers 10 mcg of formoterol via inhalation with dosing every 12 hours. Novartis currently licenses U.S. marketing rights to a similar product, Foradil Aerolizer (formoterol), to Schering-Plough. That product delivers 12 mcg of formoterol via inhalation whereby the patient inserts a capsule into the device before inhalation. The products share the same indication, although the Schering Aerolizer has broader indications for nocturnal asthma, acute prevention of exercise-induced bronchospasm and maintenance treatment for chronic obstructive pulmonary disease. Novartis told "The Pink Sheet" DAILY that it holds U.S. rights to the Certihaler, but that Schering will continue to commercialize Aerolizer. Meanwhile, Sepracor received approval for a long-acting beta2-agonist Brovana (arformoterol) for COPD in October, which is a single-isomer version of Foradil. That product is slated to launch in 2007 (1 (Also see "Sepracor COPD Treatment Approved" - Pink Sheet, 6 Oct, 2006.)). -Christopher Hollis ([email protected]) |