FDA approves Meiji’s QIDP and Fast Track Designation to ME1100September 30, 2015
Meiji Seika Pharma Co., Ltd. announced on Tuesday that the U.S. Food and Drug Administration (FDA) has designated the Company’s lead antibiotic product, ME1100 (arbekacin inhalation solution), as a Qualified Infectious Disease Product (QIDP) for the adjunctive treatment of mechanically ventilated patients with bacterial pneumonia.
FDA additionally granted fast track review of ME1100 under section 505(i) of the Federal Food, Drug and Cosmetic Act.
QIDP designation provides certain incentives under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as part of the FDA Safety and Innovation Act. These incentives include priority review and an additional five year extension of market exclusivity following product approval.
Meiji remarked that it has completed phase 1 study in health subject last year, with positive safety and tolerability findings at all doses tested in the study, and the phase 1b clinical trial is being planned to evaluate safety, tolerability and pharmacokinetics of ME1100 in patients.
“The GAIN Act is intended to encourage development of products to treat the threat posed by highly resistant ‘superbugs’. Meiji is pleased that the FDA has recognized that our product, ME1100 has value as a potential response to this urgent unmet public health need,” said Hitoshi Yamaguchi, Managing Executive Officer, Pharmaceutical Development Division of Meiji.