Phathom Pharmaceuticals, Inc. has recently received a positive response from the U.S. Food and Drug Administration (FDA) regarding their citizen petition for Voquezna (vonoprazan fumarate) new drug application (NDA) 215151. The FDA has granted the petition, acknowledging that Voquezna should benefit from the non-patent new chemical entity (NCE) and Generating Antibiotic Incentives Now (GAIN) exclusivity granted to Voquezna Triple Pak (co-package of vonoprazan fumarate, amoxicillin, and clarithromycin) NDA 215152 and Voquezna Dual Pak (co-package of vonoprazan fumarate and amoxicillin) NDA 215153.
The FDA's decision stems from the fact that vonoprazan, the active moiety first approved in the Voquezna Paks, was recognized as an NCE upon approval. As a result, the NCE exclusivity recognized for the Voquezna Paks was extended by 5 years, resulting in a total of 10 years of NCE*GAIN exclusivity with respect to the active moiety vonoprazan. Phathom Pharmaceuticals argued that this exclusivity should extend to Voquezna because it contains the same active moiety (vonoprazan), despite Voquezna not independently being designated as a Qualified Infectious Disease Product (QIDP).
The FDA's decision is based on the umbrella policy, which allows subsequently approved drug products containing the same new active moiety to benefit from the original drug product’s exclusivity until the exclusivity period for the original drug product has expired. This decision is also in line with the goal of encouraging further development and improvement of drug products containing the NCE without compromising the innovator’s exclusivity period.
As a result of these announcements, the company's shares have moved 90.19% on the market, and are now trading at a price of $8.92. For more information, read the company's full 8-K submission here.
