FDA staff plugs efficacy of projected COPD blockbuster from GSK and Theravance

GlaxoSmithKline ($GSK) and partner Theravance ($THRX) are closing in on an important advisory committee meeting for their experimental lung drug Anoro Ellipta next week. And FDA staff has noted in a briefing document that the combination therapy for COPD was effective at two doses, Bloomberg reported.

Anoro is one of several lung therapies from the collaboration between London-based GSK and Theravance, headquartered in South San Francisco. Analysts expect that the product, a combination LABA/LAMA therapy inhaled once a day, could hit $1 billion in sales, Bloomberg reported. The FDA is expected to decide whether to approve the product for COPD in December, having already stamped an approval on GSK and Theravance's Breo Ellipta for patients with the breathing ailment earlier this year.

FDA staff asked agency advisers to consider the lower of the two doses of Anoro requested for approval, yet Theravance CFO Michael Aguiar told the news service that approval of one dose would mean a victory for the program. The staffers noted some data from studies of the combo therapy could also mean a jump in cardio risk from Anoro.

As such staff reports go, GSK and Theravance made out well and managed to advance a step in the review process without any major red flags.

"Our initial read of the FDA briefing documents suggests that they are fairly benign and favorable to an approval recommendation for… Anoro for COPD," Cowen & Company analyst Anant Padmanabhan wrote this morning. Leerink Swann issued a note with a similar prediction for approval.

Glaxo is the world's largest provider of respiratory medicines, yet the pharma giant faces plenty of competition from some of the industry powerhouses and small companies in pursuit of new lung drugs. Anoro and Breo are two of the key pieces of the puzzle for GSK to stay on top of the field.

- check out Bloomberg's article