Phathom Pharmaceuticals, a pioneering biopharmaceutical company dedicated to groundbreaking solutions for gastrointestinal ailments, has announced a significant stride in its journey. The company has eagerly submitted crucial six-month stability data from its ambitious long-term and accelerated stability program, specifically tailored for its innovatively reformulated vonoprazan tablets. This strategic move is poised to accelerate the FDA’s comprehensive review of Phathom’s New Drug Application (NDA) for vonoprazan, an inventive potassium-competitive acid blocker (PCAB). This novel drug holds immense promise as a pioneering treatment for Erosive GERD (gastroesophageal reflux disease), colloquially known as erosive esophagitis.
The latest submission of these pivotal data stands as a testament to Phathom’s commitment to scientific rigor and regulatory compliance. This accomplishment effectively addresses the FDA’s earlier request for supplementary data following the issuance of the Complete Response Letter (CRL) in February 2023. This correspondence highlighted the importance of refining specifications and controls concerning a nitrosamine drug substance-related impurity, notably N-nitroso-vonoprazan (NVP). Rising to the occasion, Phathom responded by resubmitting the NDA for vonoprazan in May 2023, underpinned by three months’ worth of stability data. In a promising development, this submission has earned the drug a Priority Review designation, setting the stage for a potential landmark decision by the FDA by November 17, 2023.
“We are happy to share that the six-month stability data continue to demonstrate effective control of NVP, which is another big step forward as we prepare for a planned launch in the fourth quarter of this year. The latest stability data confirm that our minor product reformulation has limited the presence of NVP, and we believe these data comfortably support the proposed shelf life for vonoprazan tablets. We look forward to working with the FDA as it completes its review.”
– Terrie Curran, President and Chief Executive Officer of Phathom
Remarkably, the comprehensive data gleaned from Phathom’s meticulous long-term and accelerated stability program offer a resounding endorsement of the minor drug product tablet reformulation. These findings showcase the exceptional control achieved over NVP growth, impressively maintaining levels over tenfold lower than the established acceptable daily intake threshold. To put these numbers into perspective, the limit stands at 96 ng/day or 2.4 ppm, drawing reference from the approved maximum daily dose of 40 mg/day.
The underlying NDA embodies Phathom’s aspirations to secure regulatory green light for vonoprazan as a groundbreaking treatment for not only the healing and maintenance of Erosive GERD but also for the relief of the concomitant heartburn symptoms. This submission had been previously categorized as a Class 2 resubmission, underpinning the anticipation of a meticulous six-month review period. The potential ramifications of this regulatory triumph are extensive; a dual-pronged commercial launch strategy encompassing Erosive GERD and H. pylori is poised for a resounding debut in the highly anticipated fourth quarter of 2023.
Phathom’s journey is marked by scientific dedication, regulatory perseverance, and a commitment to transforming the landscape of gastrointestinal care. As the pharmaceutical industry and medical community await the FDA’s decision, the potential impact of vonoprazan on patients grappling with Erosive GERD is undeniable. The convergence of cutting-edge science and regulatory collaboration might very well lead to a new era in gastrointestinal therapeutics.
