The FDA issued a warning letter to AstraZeneca dated August 4, 2023 that cites multiple “false or misleading claims and/or representations” about the efficacy of the company’s Breztri Aerosphere (PT010) budesonide / glycopyrrolate / formoterol fumarate MDI. Breztri was approved by the FDA for the treatment of COPD in July 2020. According to the warning letter, the misleading claims appear in a “sales aid” that “misbrands Breztri within the meaning of the Federal Food, Drug, and Cosmetic Act (FD&C Act), and makes its distribution violative.”
The letter cites several statements in the promotional material that it says misrepresent data from the Phase 3 ETHOS trial, which compared Breztri to glycopyrronium / formoterol fumarate and to budesonide / formoterol fumarate. First, the agency says, the sales aid implies that ETHOS demonstrated a reduction in all-cause mortality for patients using Breztri, which the data do not support “due to the failure of the study to show statistically significant results on endpoints higher in the analysis hierarchy” and due to the potential confounding factor of sudden ICS withdrawal required for participants. The other statements cited by the letter involve claims of statistically significant reduction in severe exacerbations for Breztri compared to ICS / LABA, which the FDA says are not supported by the data.
The letter instructs AstraZeneca to respond within 15 days with a list of any other promotional materials for Breztri that include similar claims “and explaining any plan for discontinuing use of such communications, or for ceasing distribution of Breztri.” In addition, the FDA says that the company should submit “a comprehensive plan of action to disseminate truthful, non-misleading, and complete corrective communication(s) about the concern(s) discussed in this letter.”
Read the FDA warning letter.
