Egetis lands FDA approval: “Biggest milestone in the company’s history”
Swedish Egetis Therapeutics has secured FDA approval for its rare disease drug Emcitate, clearing the way for a US launch within weeks. “We are transitioning from a late-stage development biotech company into a commercial company,” CEO Nicklas Westerholm tells Life Science Focus.
The FDA has approved Emcitate (tiratricol) for adults and children with MCT8 deficiency, also known as Allan-Herndon-Dudleys syndrom, making it the first approved treatment for the rare disorder in the US.
The decision comes six months after the FDA accepted Egetis’ application and granted it Priority Review.
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