Sarepta says FDA plans faster review of drugs

Associated Press

CAMBRIDGE, Mass. (AP) — Sarepta Therapeutics Inc. said Tuesday that the Food and Drug Administration will conduct a faster review of drugs the company is developing for the deadly Ebola and Marburg viruses.

Sarepta said the FDA awarded fast-track status to AVI-7288, which is designed to treat Marburg virus, and AVI-7537, a treatment for the Ebola virus. The company is developing the drugs under a contract with the U.S. Department of Defense and neither product has been tested on humans.

Drugs that receive fast track status receive extra meetings and correspondence with regulators throughout the review process. The program is designed to speed up the approval of drugs that treat life-threatening diseases for which there are few other therapies.

The Marburg virus is indigenous to Africa and is spread through contact with infected animals or the bodily fluids of infected humans. Symptoms also include shock, delirium and multi-organ dysfunction. Sarepta said the virus is classified as a bioterrorism threat. Ebola causes severe internal bleeding and has no cure.

The company said its Marburg virus treatment is in preclinical testing and the company is planning an early-stage trial on humans. Sarepta said development of Ebola treatments under federal program is on hold because of funding constraints.

Shares of Sarepta rose 76 cents, or 5.1 percent, to $15.61 in morning trading. The company changed its name from AVI BioPharma in July.

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