An FDA expert committee has voted against Aradigm’s inhaled formulation of ciprofloxacin. Most of the panel felt Aradigm failed to provide substantial evidence of the safety and efficacy of Linhaliq in delaying the first exacerbation in patients with chronic lung infections.
The panel came down 12 to 3 against Aradigm when asked to vote about the evidence it provided. That reflected a belief that differences in the results generated in two clinical trials left doubts about the effect of the drug. Aradigm sought to alleviate these doubts by focusing the conversation on the totality of the data, but ultimately failed to sway the majority of the experts.
Bayer also struggled when it went up against the committee with its inhaled ciprofloxacin product last year. On that occasion, the panel voted 9 to 6 against a 14-day regimen of the drug. A 28-day regimen was more comprehensively rejected.
The FDA signalled Aradigm may also face a tough time in front of the experts when it released briefing documents earlier in the week. Publication of the documents sent shares in Aradigm down by more than 40% as investors digested the implications of the FDA’s concerns about the design of the phase 3 program and the data it generated.
Shares in Aradigm fell a further 46% in after-hours trading following the expert panel vote. That puts Aradigm in penny-stock territory with figures in the cash and liabilities lines of its balance sheet that suggest it may struggle to dig itself out if the FDA rejects its drug.
For now, the company can cling on to the hope that the FDA will go against the committee and clear Linhaliq for use in the U.S. The drug has a PDUFA date of Jan. 26.
Aradigm is one of several companies hoping the FDA will overlook the reservations of its committees and approve their drugs. The negative vote against Linhaliq followed similar setbacks for Lipocine and Clarus Therapeutics.