The FDA has granted five years' market exclusivity for RedHill Biopharma Ltd's RDHL Talicia under the Generating Antibiotic Incentives Now Act Qualified Infectious Disease Product designation, as recommended by the FDA Exclusivity Board.
Talicia is a fixed-dose, all-in-one oral capsule combination of two antibiotics (amoxicillin and rifabutin) and a proton pump inhibitor (omeprazole), approved by the FDA for H. pylori infection in adults.
H. pylori is a bacterial stomach infection affecting approximately 35% of the U.S. population, with an estimated two million patients treated annually.
This grant is on top of three years' exclusivity granted for the approval of Talicia under section 505(b)(2). Talicia is protected by its broad intellectual property suite to 2034.
The FDA recently approved a supplemental new drug application (sNDA) for Talicia, allowing a change to a more flexible three times daily (TID), taken at least 4 hours apart with food, and a dosing regimen for H. pylori eradication.
Price Action: RDHL shares are up 125.6% at $0.7119 during the premarket session on the last check Monday.
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