GlaxoSmithKline scores FDA nod for blockbuster COPD hopeful Anoro Ellipta

GlaxoSmithKline's ($GSK) respiratory franchise got a boost from the FDA Wednesday, and not a moment too soon. The agency green-lighted its COPD treatment Anoro Ellipta just as a generic of Glaxo's top-selling Advair won its first approval--a reminder that competition for the lung giant may be just around the corner.

According to GSK, Anoro now becomes the first once-daily COPD treatment in the U.S. to combine two drugs that relax airways in a single inhaler. And that's a coup; Anoro beat out treatments still in development at companies like Novartis ($NVS) and Forest Labs ($FRX). Partner Theravance ($THRX) will now turn over a $30 million milestone payment to Glaxo, with another $30 million scheduled for after Anoro's U.S. launch; Glaxo says it plans to begin the rollout early next year.

"We believe Anoro Ellipta will be an important treatment option for appropriate patients with COPD … This approval is a significant achievement for GSK," respiratory head Darrell Baker said in a statement.

Glaxo is counting on Anoro to star in its respiratory lineup, with analysts pegging peak sales at $1.4 billion; Bloomberg estimates say the drug could generate $1.2 billion in 2016. The Anoro approval follows May's OK for another potential COPD blockbuster, Breo Ellipta, which some have projected will surpass $1 billion by 2018.

Still, those numbers don't approach Advair's $7.7 billion, which makes up nearly a fifth of GSK's annual sales. And while Advair's difficult-to-copy inhaler technology has so far posed problems for would-be generics makers, it may not be long before competitors are knocking on Glaxo's door. One copy, a treatment from Novartis' Sandoz and partner Vectura dubbed AirFluSal Forspiro, scored its first approval Wednesday in Denmark.

But all is not lost for Advair. While the new Sandoz product contains both of Advair's active ingredients, it won't be directly substitutable for Advair, Berenberg Bank analyst Alistair Campbell told Reuters. That means it will compete with Advair like any other branded rival would; doctors will have to specifically prescribe AirFluSal Forspiro over Advair. The generic version will also need payer approval in each country before launching, which could take awhile.

But if the FDA has its way, Advair could be facing competitors in the U.S. sooner than GSK would like. After releasing "relatively basic" draft guidance for generic versions of combination inhaled drugs like Advair, the agency announced plans in November to shorten the review process for those drugs.

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