As AstraZeneca tussles with British compatriot GlaxoSmithKline in the respiratory arena, it has nabbed its first global approval for Breztri Aerosphere, a three-in-one COPD inhaler that could rival GSK’s Trelegy Ellipta.
The Japanese Ministry of Health, Labor and Welfare approved Breztri, AZ said on Wednesday, along with the company's two-drug COPD combo Bevespi. The Breztri triplet is also under priority review in China with a decision expected later this year, while the U.S. and EU regulators could deliver their decisions next year.
Besides the power that comes with three drugs, AZ is also counting on the Aerosphere inhaler technology to set it apart. The device's co-suspension technology helps keep dosing consistent for combo drugs delivered via an inhaler.
Formerly known as PT0101, Breztri combines budesonide, glycopyrronium and formoterol, while Bevespi loses the budesonide component. That ingredient is used in AZ’s very own Pulmicort and formoterol dual-drug combo Symbicort.
In the 1,900-patient Kronos trial, Breztri beat Symbicort and other two-drug inhalers in terms of improvement in forced expiratory volume in one second (FEV1)—which measures breathing ability—at almost all points over a period of 24 weeks. The one shortfall among nine primary endpoints came in comparing Breztri to Bevespi at week 24. But AZ quickly pointed out that Breztri did post a numerically favorable trend, just not a strong enough one to pass the statistically significant threshold.
AZ and GSK have long been locked in a tight fight in the respiratory field. But at least for three-drug COPD inhalers, GSK has one leg up. After an initial approval in September 2017, Trelegy contributed £156 million ($197 million) to GSK’s top line in 2018. That means if AZ finally gets its U.S. approval in 2020, Trelegy will have already been on the market for more than two years.
Both companies' respiratory profiles have been under some pressure lately. For GSK, sales of Advair plummeted in the face of pressure from newer drugs and a copycat assault by Mylan’s Wixela Inhub. Symbicort, once AZ’s bestselling medicine, also saw sales decline 9% to $2.56 billion in 2018 due to increased competition in the U.S.
Of course, they are both trying to steal share from each other. In a head-to-head phase 3 trial, AZ’s Bevespi failed to beat GSK’s Anoro Ellipta on both peak FEV1 and trough FEV1. In 2018, Bevespi only raked in $33 million, versus Anoro’s £476 million ($600 million), which itself represented a 39% year-over-year jump.
Respiratory diseases such as asthma and COPD are a major health burden in the U.S., and increasingly so in developing countries as they urbanize. Understandably, the big market has attracted much interest from the biopharma industry. According to PhRMA’s latest Medicines in Development for Asthma and Allergy report released in February, 54 drugs for asthma and 39 for COPD were in clinical development or awaiting review by the FDA.