Still no green light for Phathom's gastrointestinal drugs after impurities found in batches

2023-02-10

上市批准申请上市引进/卖出并购

Phathom Pharmaceuticals is still working out the kinks of launching two already-approved drugs for a bacterial infection and snagging an NDA approval for another gastrointestinal indication after impurities were found in the first commercial batches. Following official rejections, the Takeda spinout plans to meet again with the FDA within the first quarter of this year to talk about the resubmission and timeline for an NDA for vonoprazan for erosive esophagitis as well as the launch of two drug combo treatments for Helicobacter pylori ( H. pylori ) bacterial infections. T he company said the FDA sent complete response letters for both the NDA and a post-approval supplement to “address specifications and controls for a nitrosamine drug substance related impurity, N -nitroso-vonoprazan.” The FDA first decided to take no action on the vonoprazan NDA last month . The impurity was found in commercial batches of Voquezna Triple Pak and Voquezna Dual Pak, which are already approved for the treatment of H. pylori infections. That launch, as well as the NDA decision for vonoprazan as a treatment for erosive esophagitis, are delayed. In May 2022, the FDA approved vonoprazan in combination with other products for H. pylori infections in adults: Voquezna Triple Pak combines vonoprazan tablets with amoxicillin capsules and clarithromycin tablets, while Voquezna Dual Pak contains vonoprazan and amoxicillin. Phathom has been investigating the root cause of the contamination and has already implemented measures to keep the impurity at acceptable levels: 96 ng/day throughout the shelf life of the product. Terrie Curran, president and CEO of Phathom, said in a statement that the company has made progress on generating the necessary data to show the impurity is under control. “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,” Curran said. “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.” Vonoprazan, an oral potassium competitive acid blocker that blocks acid secretion in the stomach, is already approved in Japan. Takeda spun it into Phathom with the help of Frazier in 2019. If the FDA approves the product, it will be manufactured by Kentucky-based Catalent, which inked a deal with Phathom in 2021.

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