Infectious Disease

Vonoprazan stalled for esophagitis, H. pylori as FDA cites nitrosamine impurity concerns

February 14, 2023

2 min read

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The FDA has rejected Phathom Pharmaceutical’s vonoprazan new drug application for erosive esophagitis, as well as its post-approval supplement for Helicobacter pylori, due to the presence of nitrosamine impurities.

According to a company press release, the FDA has requested that Phathom provide “additional stability data to demonstrate that levels” of the nitrosamine-related impurity, N-nitroso-vonoprazan (NVP) — initially detected in the commercial launch materials for the Voquezna Triple Pak and Voquezna Dual Pak products — will remain at or below the daily acceptable intake throughout the shelf life of the product.

Source: Adobe Stock.

Source: Adobe Stock

“We remain encouraged with the progress we have made in generating additional stability data to meet FDA’s request and are eagerly awaiting our meeting with the FDA anticipated later this quarter to discuss our ongoing efforts, share our data and gain alignment on resubmission and potential approval timelines ,” Terrie Curran, president and CEO of Phathom, said in the release. “We are pleased that no other review issues were cited related to our erosive esophagitis NDA and that our labeling discussions continued to progress since our announcement last month, resulting in a near final label.”

In January, the FDA notified Phathom that due to NVP impurities, “no action will be taken on the company’s new drug application for vonoprazan” by the original Prescription Drug User Fee Act target action date of Jan. 11, 2023. Considering this regulatory delay , Phathom has opted to postpone the commercial launches of Voquezna Triple Pak and Voquezna Dual Pak for H. pylori, originally planned for the first quarter of 2023.

Although an acceptable daily intake limit for NVP has now been established by the FDA at 96 ng/day, Phathom noted it has conducted extensive root cause investigations regarding the trace levels of the impurity and has implemented mitigation measures to maintain NVP levels below the acceptable intake .

“We are confident that our ongoing stability program will generate the required data and will clear the pathway to potential approval and launch of these important products for patients in need of new treatment options for erosive esophagitis and H. pylori infection,” Curran said in the release.

Phathom expects to meet with the agency within the first quarter of 2023 to discuss the resubmission plan and timeline for products containing vonoprazan.

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