FDA Grants Fast Track Designation to Ebola, Hemophilia B Drugs

The FDA granted fast track designation to a drug from Mapp Biopharmaceutical to treat the Ebola virus and to Dimension Therapeutics to treat patients with hemophilia B.

ZMapp is being evaluated in the U.S. and Liberia, comparing the drug with supportive care methods such as rehydration and medications to stabilize blood pressure, oxygen levels and electrolytes. If the trial finds that ZMapp improves survival beyond supportive care’s 20 percent to 40 percent mortality rate, it will become the new standard of care.

Mapp Biopharmaceutical has been working on Ebola treatments for more than a decade, the San Diego, Calif., firm said.

Dimension Therapeutics

Dimension Therapeutics obtained the same designation for its lead candidate DTX101 to treat patients with hemophilia B.

Dimension expects to initiate a multi-center Phase 1/2 study to evaluate DTX101 in adult patients with moderate/severe to severe hemophilia B by the end of this year, the company announced last week.

DTX101 is designed to deliver blood clotting Factor IX gene expression in patients with the disease, Dimension says. The current standard of care involves chronic replacement of FIX protein through intravenous infusion.

Through the fast track program, a product may be eligible for priority review, and may be eligible to submit sections of the BLA on a rolling basis as data become available. The designation also provides opportunities for frequent interactions with the FDA. — Kellen Owings and Jonathon Shacat