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By Colin Kellaher
Altimmune has won U.S. Food and Drug Administration fast-track designation for its lead product candidate pemvidutide in the treatment of nonalcoholic steatohepatitis, the chronic liver condition commonly known as NASH.
The Gaithersburg, Md., clinical-stage biopharmaceutical company on Thursday said it is studying the efficacy and safety of pemvidutide in NASH in a Phase 2b placebo-controlled biopsy-driven trial.
The FDA’s fast-track program is designed to facilitate the development and expedite the review of treatments for serious or potentially life-threatening illnesses with high unmet medical needs.
There are currently no FDA-approved drugs to treat NASH, which is caused by a buildup of fat in the liver and is estimated to affect 17 million Americans.
Write to Colin Kellaher at [email protected]
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