The Food and Drug Administration (FDA) will fast-track a review of Eagle Pharmaceuticals’ Ryanodex drug to treat exertional heat stroke (EHS) following positive clinical trial data.
The process is tentatively scheduled to be completed in six months, and the drug on the market later this year, according to an Eagle Pharmaceuticals company press release.
The FDA’s accelerated review is reserved for medicines that either represent great strides forward or fill a void in the market, according to the release. Officials with Eagle think Ryanodex meets both criteria.
"There is currently no approved pharmacological treatment for EHS," Eagle CEO Scott Tarriff said in a press release. “If Ryanodex is approved, Eagle will be the first to market with a potentially transformational therapy.”
David Pernock, president and chief commercial officer, said in the release that the 75,000 cases of heat stroke annually may be conservative.
“Ryanodex will represent Eagle’s most significant self-launched commercial product, and we are continuing to build our commercial capabilities to serve the healthcare profession upon approval," Pernock said.
According to a February 2015 FDA ruling, the drug, which in controlled studies helped patients recover faster than cooling alone, has a seven-year window in which it will be the sole treatment of malignant hyperthermia in the United States.
FDA gives priority review to Eagle Pharmaceutical's heat stroke drug
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