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July 31, 2020

AstraZeneca’s Breztri Aerosphere Finally Receives FDA Approval for COPD and Will Later Address Unmet Need in Asthma

On July 24, AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) was finally approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), almost ten months after it received a complete response letter from the FDA.

By GlobalData Healthcare

On July 24, AstraZeneca’s Breztri Aerosphere (budesonide/glycopyrrolate/formoterol fumarate) was finally approved in the US for the maintenance treatment of patients with chronic obstructive pulmonary disease (COPD), almost ten months after it received a complete response letter from the FDA.

Despite its late market entry, GlobalData believes Breztri Aerosphere will catapult ahead and achieve blockbuster sales in the next decade, not only in COPD patients but eventually those with moderate to severe Asthma too.

Key opinion leaders (KOLs) interviewed by GlobalData have indicated that physicians are keen to switch patients who are currently receiving inhaled corticosteroids (ICS), long-acting beta agonists (LABA), and long-acting muscarinic antagonists (LAMA) in separate devices to a combination inhaler of ICS/LABA/LAMA to improve overall adherence. Physician familiarity with the prescribing patterns for AstraZeneca’s Symbicort’s (budesonide + formoterol fumarate) will add momentum to Breztri Aerosphere’s market access strategy. Although KOLs showed interest in GlaxoSmithKline’s once-daily Ellipta device, they were not particularly enthusiastic about the active ingredients (fluticasone + umeclidinium + vilanterol), and much preferred those of AstraZeneca’s Breztri Aerosphere.

With GlaxoSmithKline, Chiesi, and Novartis all pushing for their triple inhaled therapies to have a place in asthma treatment, AstraZeneca will also look to capitalize on this with Breztri Aerosphere in the near future, especially with the change in global asthma guidelines from 2019.

The Global Initiative for Asthma guidelines now advise using ICS/LABA, such as Symbicort, as a rescue therapy instead of short-acting beta agonists (SABA). Still, Symbicort can be used as rescue treatment alongside Breztri Aerosphere as a maintenance therapy. The two complement each other as they share the same active ingredients, meaning there is less ambiguity when it comes to corticosteroid compatibility. GlobalData believes that Breztri Aerosphere will reach blockbuster levels of sales over the next decade, supported by swift uptake in patients with moderate to severe asthma upon approval.

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