February 10, 2023 8:53 AM | 1 min read
- The FDA has formally asked for additional stability data to demonstrate that levels of the impurity previously found in Phathom Pharmaceuticals Inc’s PHAT vonoprazan drug product will remain at or below the daily acceptable intake throughout the proposed shelf life of the product.
- The FDA cited no additional deficiencies in either letter.
- In August 2022, Phathom detected trace levels of a nitrosamine in vonoprazan drug product in post-approval testing as we prepared for commercial launch.
- These additional activities delayed Voquezna Dual Pak And Voquezna Triple Pak product launches, with the full commercial launch of these products and, if approved Voquezna tablets for erosive esophagitis that were expected in Q1 of 2023.
- Phathom has conducted extensive root cause investigations regarding the trace levels of the impurity since it was detected and has implemented mitigation measures to control the levels of N-nitroso-vonoprazan below the acceptable intake.
- Phathom expects to meet with the FDA in the first quarter of this year to discuss the resubmission plan and timeline.
- In January, the FDA delayed a decision on vonoprozan for erosive esophagitis.
- Price Action: PHAT shares are down 23.84% at $8.86 premarket on the last check Friday.
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