AstraZeneca's latest respiratory win could spur Bevespi approvals in China, Japan

AstraZeneca HQ
AstraZeneca's Bevespi Aerosphere won U.S. approval last year.

Earlier this month, AstraZeneca rolled out positive results for a LAMA/LABA combo COPD med it hopes to bring to the U.S. market. And now, it’s followed up with positive results for another LAMA/LABA that could help the company gain a respiratory foothold in Asia.

In a phase 3 trial, Bevespi Aerosphere—a marriage of glycopyrronium and formoterol fumarate—outperformed pairings of its two individual components with placebo at improving lung function, AZ said. And it’ll take those results, as well as data from previous trials, to regulators in China and Japan next year.

Bevespi hit the U.S. market after an approval last April, joining GlaxoSmithKline’s Anoro Ellipta and Boehringer Ingelheim’s Stiolto Respimat in the LAMA/LABA space.

RELATED: New data in hand, AstraZeneca gears up to take Duaklir into crowded U.S. COPD space

And AZ is looking to add another newcomer to the crowded field, too: Duaklir, a pairing of aclidinium bromide and formoterol that in early September showed it could beat out its component meds at improving lung function. The British pharma giant gained access to that med with a 2014 deal for Almirall’s respiratory portfolio.

While payers have been tough on the respiratory space, putting the squeeze on pharmas to keep prices down, AstraZeneca knows how to play the game. Its aggressive discounting on Symbicort helped accelerate a market-share slide for GlaxoSmithKline behemoth Advair a few years back, though GSK ultimately responded with its own hefty price cuts.

RELATED: GlaxoSmithKline, needing a sales surge, wins FDA nod for $1B-plus prospect Trelegy

Meanwhile, last week Glaxo took respiratory treatment to the next level, winning FDA approval for the U.S. market’s first so-called closed triple that combines a LAMA and a LABA with a corticosteroid in a single inhaler. AstraZeneca and Novartis are both working on their own closed triples, but former GSK CEO Andrew Witty has predicted that it’ll be close to impossible to catch up.

On last year’s second-quarter conference call, Witty said he believed the closed triple approval would be “the thing that really clinches the market,” adding that “if you decide that your triple of choice is the GSK triple, then why wouldn't you start with a double of GSK? Why on earth would you start with somebody else's double?”