Breztri Asthma Approval Shows How a Drug Gains a New Indication

AstraZeneca said on April 28 that the Food and Drug Administration has approved its triple-combination inhaler Breztri Aerosphere for the maintenance treatment of asthma in adults and children 12 and older. The company's release said the approval was based on the Phase III KALOS and LOGOS trials, which compared Breztri with two-drug inhalers in about 4,300 randomized patients, and that results were published in The Lancet Respiratory Medicine in February. Breztri, which combines budesonide, glycopyrrolate and formoterol, was approved in the U.S. in 2020 for chronic obstructive pulmonary disease, the company said.

Breztri was not approved again from scratch. It gained a second use through a supplement to its existing application.

What an efficacy supplement is

FDA's approval letter, dated April 27, refers to supplement S-009 to new drug application 212122. It says AstraZeneca submitted the supplemental new drug application on June 27, 2025, and that the "Prior Approval supplemental new drug application provides for the addition of the indication of the maintenance treatment of asthma in adult and pediatric patients 12 years of age and older." It also introduces a new strength of the inhaler. Drugs@FDA lists the action under the category "Efficacy-New Indication."

FDA's drug application regulations, at 21 CFR 314.3, define an efficacy supplement as a supplement to an approved NDA proposing related labeling changes from a set list. The list includes adding or modifying an indication or claim, revising the dose or regimen, adding a route of administration, making a comparative efficacy claim naming another drug, significantly altering the intended patient population, and switching from prescription to over-the-counter use.

The evidence bar does not drop for a supplement. In an unrelated April 16 announcement inviting testosterone makers to discuss supplemental applications for a possible new use, FDA said that "any approval for a new indication would require demonstration of substantial evidence of effectiveness and that the benefits outweigh the risks for the intended population."

What comes with the approval

A supplement approval brings its own conditions. The Breztri letter requires updated labeling to be submitted in structured format within 14 days, and reminds the company of reporting requirements for approved applications. It also tells AstraZeneca to submit patent information for listing in the Orange Book within 30 days where the supplement's changes call for it.

New indications also trigger the Pediatric Research Equity Act, which, the letter notes, requires applications for new indications to assess the product in children unless the requirement is waived, deferred or inapplicable. FDA waived studies from birth to under 4, finding them impossible or highly impracticable, and deferred studies in children 4 to under 12 because the product was ready for approval in older patients. The deferred work is listed as three required postmarketing studies, including a 52-week efficacy and safety study in children 4 to 11, with a final report due in June 2035. FDA said the product is appropriately labeled for ages 12 to under 18, so no further studies are needed in that group.

AstraZeneca said the trials identified no new safety or tolerability signals, and that applications for Breztri in asthma are under review in the European Union, Japan and China. The approval does not change the inhaler's role, the company said: Breztri is a maintenance therapy and will not replace a rescue inhaler.