AZ trumpets positive COPD data to help Symbicort stand up to rivals

The already crowded COPD field is only going to get more competitive going forward--but AstraZeneca is boasting new data it hopes will keep its player going strong.

Last week, the British drugmaker trumpeted top-line results from a study in which ICS/LABA drug Symbicort met its primary endpoint, beating out formoterol Turbuhaler at cutting down on exacerbations in patients with severe forms of the disease.

It’s good news for the company, which has been working to weasel market share away from GlaxoSmithKline giant Advair in the U.S. as it fights off a European Symbicort generic from Teva. The company plans to consider “additional regulatory submissions” based on the results of the study, it said.

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Problem is, two of its fierce competitors have also recently touted exacerbation-reducing data. Back in May, Novartis’ Ultibro Breezhaler--a LAMA/LABA combo med approved in Europe--showed it could top Advair in that department, marking what the Swiss drugmaker’s CMO called “a shift away from therapies containing steroids for the optimal treatment of COPD patients."

But Symbicort’s fellow ICS/LABA drug, Breo--GSK’s Advair follow-up--posted exacerbation-cutting results of its own later in the month, showing that the product bested “usual care”--including LAMAs, LABAs and ICS regimens.

Meanwhile, all three drugmakers are bracing themselves for U.S. generic Advair competitors, which are on the way from copycats including Mylan. It’s unclear, though, when they’ll actually hit, and Glaxo chief Andrew Witty has suggested it could still be awhile.

In the interim, AZ is doing what it can to bolster the rest of its respiratory portfolio, which it needs to achieve the sky-high $45 billion sales target CEO Pascal Soriot has put up for 2023.  It won an FDA green-light for LAMA/LABA contender Bevespi Aerosphere in April, and it’s hoping the co-suspension technology in its inhaler device will help set it apart from the other LAMA/LABAs--including GlaxoSmithKline’s slow-starting Anoro Ellipta--that beat it to the U.S. market.

And it’s not stopping there with the new tech: It’s also applying it to “a range” of inhaled cocktail therapies in its pipeline, including a fixed-dose LAMA/LABA/ICS triple combo.

Separately, AZ last week released positive results for Symbicort in pediatric asthma, which it generated to fulfill the terms of a complete response letter the FDA issued in 2009.

- read AZ's release

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