The FDA has halted talks about the labeling of Cosmo Pharmaceuticals’ colon coloring agent after identifying deficiencies with the filing. Cosmo had hoped to win FDA approval for the agent later this month.
Little is known publicly about the setback at this time. Cosmo said the FDA is yet to provide details of the deficiencies it identified, leaving it and the public unsure about the severity of the setback. The company expects to receive clarification from the FDA by the May 21 PDUFA date and plans to work with the agency to get back on track as soon as possible.
Cosmo went to the FDA armed with data from a clinical trial of more than 1,000 patients. The results linked its candidate, a methylene blue coloring agent, to greater detection of adenomas than was achieved using white light endoscopy.
That finding resulted in the trial meeting its primary endpoint and appeared to put Cosmo on a solid footing ahead of talks with the FDA. However, something has gone awry, prompting the FDA to stop discussions of the product’s labeling and postmarketing requirements.
With Cosmo having solid phase 3 data on the effectiveness of its coloring agent in the bank, observers are hopeful of a short delay. However, the lack of detail means a longer setback is possible.
“At this time we cannot exclude the potential scenario of a 6-12 month delayed approval if incremental data/analysis must be submitted, or a perhaps unlikely 'worst' case of a prolonged setback if further clinical data are required,” Jefferies analyst Peter Welford wrote in a note to investors.