Prothena Receives FDA Fast Track Designation for PRX012 for the Treatment of Alzheimer's Disease

Prothena Corporation plc PRTA announced that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation for the anti-amyloid beta (Aβ) antibody therapy drug candidate PRX012 for the treatment of Alzheimer's disease.

PRX012 is a potential best-in-class, subcutaneous anti-amyloid beta antibody therapy from Prothena, currently in a Phase 1 clinical study for the treatment of Alzheimer's disease.

Gene Kinney, Ph.D., President and Chief Executive Officer, said, “We welcome the FDA's decision to grant PRX012 Fast Track designation, which is designed to bring important new drugs to patients sooner, and we look forward to collaborating with the FDA to expedite the development of this investigational next-generation amyloid beta-targeting therapy for the millions of patients with Alzheimer's disease and their families”.

The Fast Track designation program is designed to expedite the development and review of drugs intended to treat a serious condition, such as Alzheimer's disease, with evidence demonstrating the potential to address an unmet medical need.

Prothena Corporation is trading up 3.8 percent at $34.50 in the premarket trading.