FDA sends warning to AstraZeneca on misleading COPD therapy promotional communications

Key takeaways:

• The FDA found that AstraZeneca made misleading claims about Breztri Aerosphere for COPD in sales material.
• These claims inaccurately describe the drug’s ability to reduce death and severe exacerbations.

Due to misleading claims in a sales aid for Breztri Aerosphere, a triple inhaled therapy for COPD, the FDA has issued a warning letter to its manufacturer, AstraZeneca.

Breztri Aerosphere is a pressurized metered-dose inhaler containing budesonide, an inhaled corticosteroid; glycopyrrolate, a long-acting muscarinic antagonist; and formoterol fumarate, a long-acting beta agonist.

According to the FDA warning letter, promotional communication for Breztri Aerosphere may mislead patients with COPD into thinking the treatment decreases all-cause mortality risk by stating, “An observed relative difference with Breztri vs. LAMA/LABA was shown in data published in 2020/2021, including in The New England Journal of Medicine;” however, the references included by the manufacturer did not support this claim.

The promotional aid references the Efficacy and Safety of Triple Therapy in Obstructive Lung Disease (ETHOS) trial, of which all-cause mortality was a secondary endpoint. The FDA warning letter notes that “endpoints higher in the analysis hierarchy” were not statistically significant in the trial, so the claim made in the sales aid does not properly state known benefits of the treatment.

Additionally, AstraZeneca claims that the treatment “was the ONLY triple therapy vs. ICS/LABA to show a significant reduction to severe exacerbations” over 52 weeks in the ETHOS trial and includes a P value of 0.02, but the FDA found that this claim cannot be backed up by the trial.

When comparing patients taking Breztri Aerosphere with those taking ICS/LABA, researchers from the ETHOS trial did not observe a statistically significant reduction in severe exacerbations because the P value was greater than the critical value of the test.

“These violations are concerning from a public health perspective because the promotional communication creates a misleading impression regarding the overall benefits a patient may expect as a result of Breztri treatment,” Twyla Mosey, PharmD, director of the division of advertising and promotion review 2 in the Office of Prescription Drug Promotion, said in the warning letter.

The FDA is requesting a response from AstraZeneca on these claims within 15 business days of receipt.

Reference:

• Breztri Aerosphere promotional material. https://www.fda.gov/media/171157/download?attachment. Accessed Aug. 16, 2023.