FDA decision, launch of gastrointestinal drug delayed after nitrosamine found in commercial batches

Takeda spinout Phathom Pharmaceuticals’ lead gastrointestinal drug has hit a snag with the FDA, the company announced Tuesday, and won’t hit the market until after the first quarter of 2023.

The FDA won’t take any action on the NDA for vonoprazan as a treatment of erosive esophagitis because trace levels of nitrosamine impurities were found in commercial batches, Phathom said.