Boehringer Ingelheim has filed a citizen petition with the FDA asking the agency to “request the Commissioner of Food and Drugs to ensure that any New Drug Application (“NDA”) for a fixed-dose, triple-combination, inhaled drug product intended for the treatment of patients with chronic obstructive pulmonary disease (“COPD”) is not approved as safe and effective unless it meets the requirements of the Combination Rule set forth at 21 C.F.R. § 300.50.”
The petition notes that in November 2016, GSK announced that it had submitted an NDA for a fluticasone furoate/umeclidinium/vilanterol DPI for the treatment of COPD based on data from the Phase 3 FULFIL study which compared the product to Symbicort Turbuhaler budesonide/formoterol.
Boehringer Ingelheim claims that the FULFIL study does not meet the requirements of the Combination Rule, and the petition asks the FDA to “to refrain from approving any NDA for a fixed-dose, triple-combination, inhaled drug product intended for the treatment of patients with COPD unless the application is supported by pivotal clinical studies that satisfy the requirements of the Combination Rule. Specifically, the Commissioner should refrain from approving any such NDA unless:
1. It is supported by pivotal, Phase III clinical trials that use active comparators containing the same active ingredients as those contained in the proposed triple combination therapy, not simply active ingredients in the same therapeutic categories; and
2. It is supported by pivotal, Phase III clinical trials that utilize a factorial design adequate to demonstrate that each active ingredient in the proposed triple-combination makes a contribution to the claimed effects. The most critical comparison in any factorial study of a triple combination of an inhaled corticosteroid (“ICS”), long-acting muscarinic agent (“LAMA”) and long-acting β2-agonist (“LABA”) should be with the dual combination of the LAMA+LABA components. This is the only way to determine whether or not the ICS component, which is not a bronchodilator, contributes a meaningful improvement in bronchodilation when that is the indication being sought.”
The petition also requests that “if FDA receives an NDA for a proposed triple-combination that does not meet the Combination Rule standards described in this petition, it should refer the application to the Pulmonary-Allergy Drugs Advisory Committee prior to acting on it.”
Read the Boehringer Ingelheim citizen petition.
