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# FDA Denies BI Petition to Block GSK Trelegy Ellipta
- URL: https://www.fdaweb.com/fda-denies-bi-petition-to-block-gsk-trelegy-ellipta/
- Published: 2017-09-19T12:00:00.000Z
- Updated: 2026-09-14T22:51:16.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5139665

FDA has denied a Boehringer Ingelheim petition seeking to have FDA impose conditions for approving any NDA for a fixed-dose, triple-combination, inhaled drug product intended to treat patients with chronic obstructive pulmonary disease (COPD). In its denial [letter](https://www.regulations.gov/contentStreamer?documentId=FDA-2017-P-3684-0004&attachmentNumber=1&contentType=pdf&ref=fdaweb.com), the agency said it was approving GlaxoSmithKline’s Trelegy Ellipta (fluticasone furoate 100 mcg, umeclidinium 62.5 mcg, and vilanterol 25 mcg inhalation powder). The letter says it is the first approved inhaled COPD product containing an inhaled corticosteroid, long-acting beta-agonist, and long-acting muscarinic antagonist.

“It is the agency’s position that GSK has provided adequate data to support a claim of improved airflow obstruction for Trelegy Ellipta in the population of patients already taking Breo, or already taking Breo and Incruse via separate inhalers,” the denial letter concludes. The agency said that rather than the strict conditions on approval sought by Boehringer Ingelheim in terms of Phase 3 trials using active comparators with the same active ingredients, trials with an adequate factorial design, and convening a meeting of the Pulmonary-Allergy Drugs Advisory Committee, FDA takes a more flexible approach in working with sponsors to ensure that adequate safety and efficacy data are developed.