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

AstraZeneca will file an FDA application for Duaklir in the first half of next year, it says.

AstraZeneca has some positive new COPD data in handand it’s data that could help the company snag a new approval.

In a phase 3 study, the British drugmaker’s Duaklira pairing of its aclidinium bromide, also known as Tudorza, and formoterolhit its primary endpoints, outperforming each of its components individually at improving lung function in patients with moderate to severe COPD.

The pharma giant expects to take those results right to regulators; it’s on track to submit a new drug application to the FDA in the first half of next year, it said.

The “top-line results provide further clinical evidence of Duaklir's efficacy and support making this LAMA/LABA combination treatment option available to COPD patients in the U.S.,” Steve Lewington, the global medicine leader for AZ’s respiratory unit, said in a statement.

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AstraZeneca first gained access to Duaklir in 2014, when it sealed a deal for Almirall’s respiratory portfolio. The company inked a pact worth up to $2.2 billion including milestones to back up aging Symbicort, a blockbuster under pressure from advancing generic and branded rivals alike.

It scored a quick payoff just a few weeks after the deal’s close, winning an EU approval for the med. The only problem? A crowded market, which the U.S. also features. Stateside, Duaklir will go up against meds including GlaxoSmithKline’s Anoro and Boehringer Ingelheim’s Stiolto, both of which have faced plenty of payer arm-twisting.

AstraZeneca needs all the revenue boosts it can get, though, if it wants to meet the lofty $45-billion-by-2023 sales goal CEO Pascal Soriot posted to help dodge a Pfizer bid back in 2014. Last year, the company pulled in product sales of $21.32 billionsubstantially less than 2014’s $26.10 billion haul—with the respiratory unit chipping in $2.99 billion.