Last week FDA staffers came up with a lukewarm review of the efficacy seen in Boehringer Ingelheim's prospective COPD drug olodaterol, but couldn't fault its safety profile. And that seemed to satisfy the panel of outside experts who met to review the drug today, giving it a pass with a lopsided 15-to-1 vote in favor of approval.
"We at Boehringer Ingelheim are pleased with the advisory committee's recommendation and look forward to continuing to work with the FDA as the agency continues its review of the olodaterol NDA," said Tunde Otulana, the vice president of clinical development and medical affairs, respiratory, for Boehringer Ingelheim Pharmaceuticals. "The positive vote from the advisory committee marks an important step towards making olodaterol available to the approximately 24 million patients with COPD in the United States."
If history is any guide, and it is here, the FDA's approval should be relatively straightforward in the wake of a vote like this, unless some nasty surprise awaits on the sideline. But even with an approval, Boehringer would be headed to the market with a new therapy that only earned a quick nod for its "modest" impact on patients. How that would stack up with payers, though, as GlaxoSmithKline ($GSK) and Theravance ($THRX) await their own green light, Novartis ($NVS) advances its top late-stage drug QVA149 and other developers like Pearl Therapeutics possibly come along with COPD drugs of their own, will take some time to assess.
Boehringer is looking to launch Striverdi Respimat as a once-daily inhaled therapy for the chronic lung disease in what looks like an increasingly crowded field of developers. But for now, the advisers are satisfied with what's on the table.
"It was a great thing they did and the best we have right now and I believe it's going to push us in a more comprehensive fashion in the future," said Bill Ameredes, an adviser from the University of Texas Medical Branch's pulmonary division in Galveston, according to Bloomberg.