The FDA is demanding new data from Novartis for its diabetes drug Galvus, delaying any potential approval by a year. The agency is requiring Novartis to mount a new study of Galvus to assess kidney impairment. The decision is a significant setback for Novartis, which has avidly sought an approval of the drug. European regulators are currently considering Galvus for approval.
"We are confident in the safety and efficacy of Galvus and will continue working closely with the FDA to agree on what final actions are required to obtain U.S. approval," said James Shannon, global head of development at Novartis.
- check out the press release on the delay
- here's the AP report on the FDA's decision