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FDA questions impact of Boehringer's lung drug

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An FDA staffer dished out a lukewarm evaluation of the efficacy of Boehringer Ingelheim's respiratory treatment olodaterol, writing in a briefing that the inhaled therapy showed "modest" benefits in study patients with smoker's cough or chronic obstructive pulmonary disease.

The agency posted the assessment in a document for an advisory panel of outside experts, who meet Jan. 29 to review the German drugmaker's application for U.S. approval. Boehringer is shooting for a green light for the drug, under the proposed brand name Striverdi Respimat, as a once-daily inhaled treatment for COPD, where there is heated competition with existing drugs and those under review such as Breo and Relvar, from GlaxoSmithKline ($GSK) and Theravance ($THRX).

"Although the magnitude of the treatment effect is somewhat modest in the 48-week trials, this may be related to the baseline COPD medications allowed in those trials," the FDA's Dr. Theresa Michele wrote to the panel. "Whether or not this modest treatment effect in the setting of other baseline medications is sufficient to warrant a bronchodilator claim for olodaterol will be a topic of discussion at the [advisory panel] meeting."  

In Bloomberg's translation, the FDA staff is questioning whether the non-agency advisers should recommend approval based on the unexceptional benefits seen in trials. The agency, of course, will weigh the committee's advice in deciding whether to approve the drug.

The agency's report raised no red flags about the safety of olodaterol, which Boehringer is also studying in combination with its approved respiratory med tiotropium. That would give the company a LABA/LAMA combo to rival GSK and others in the crowded field.

- download the FDA briefing doc here
- check out Bloomberg's article

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