Phathom Pharmaceuticals provides regulatory updates for for its approved products, Voquezna Triple Pak and Voquezna Dual Pak

Phathom has received complete response letters from the FDA relating to its erosive esophagitis NDA and H. pylori post approval supplement, both of which address specifications and controls for a nitrosamine drug substance related impurity, N-nitroso-vonoprazan (NVP), that was detected in the initial commercial launch materials of Voquezna Triple Pak and Voquezna Dual Pak.

These letters formalize FDA’s request, announced by the Company last month, that Phathom provide additional stability data to demonstrate that levels of the impurity previously found in vonoprazan drug product will remain at or below the daily acceptable intake throughout the proposed shelf life of the product. No additional deficiencies were cited by the FDA in either letter.

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 NVP 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 that the Company believes will lead to approval and launch of products containing vonoprazan.