Boehringer snags EU nods for COPD drug as FDA awaits

Boehringer Ingelheim has won over European regulators with its latest COPD therapy, following a favorable FDA panel vote that set the stage for U.S. approval and entrance into a huge but crowded market.

Striverdi Respimat, née olodaterol, is a long-acting beta2 agonist (LABA) taken once daily to treat COPD, and thanks to some positive Phase III data, the drug has made its European landfall with approvals in the U.K., Denmark and Iceland.

The drug, a successor to Boehringer's $4.7 billion-a-year Spiriva franchise, is the German giant's latest effort to treat a disease that kills millions a year around the globe. The treatment won an uninspiring thumbs up from an FDA panel early this year, as agency advisers found nothing wrong with Striverdi but also little that sets it apart from COPD treatments already on the market. That victory makes FDA approval almost certain, but Boehringer may well face an uphill battle convincing payers to reimburse for a treatment that offers only modest benefits over GlaxoSmithKline's ($GSK) soon-to-be-generic Advair.

Some analysts predict the market for COPD drugs will soar to $18 billion by 2018 from $10 billion this year, and Boehringer is among a cadre of drug developers angling to take the lead with next-generation therapies. GSK and Theravance ($THRX) have already made it to the market with Advair's replacement, Breo, a LABA treatment predicted to rake in up to $1 billion by 2018. Both Striverdi and Breo bank on the idea that patients and payers will pony up for a once-daily COPD treatment that isn't leagues beyond what's already on the market.

Perhaps the most promising of the new crop of COPD treatments is Novartis' ($NVS) QVA149, approved in Europe last month as the Ultibro Breezhaler. The treatment combines a long-acting muscarinic antagonist (LAMA) with standard LABA, and Phase III data found the drug beat out competitors in relieving symptoms. Analysts expect Novartis to pick up an FDA nod for the drug some time next year, and GSK and Boehringer are in the midst of developing LAMA/LABA treatments of their own.

- read Boehringer's announcement