Flexion's Zilretta NDA accepted for US review

7 February 2017

US drugmaker Flexion Therapeutics (Nasdaq: FLXN) today announced that the US Food and Drug Administration has accepted for filing the company’s New Drug Application for its lead investigational product candidate Zilretta (also known as FX006).

Zilretta is being evaluated as a new treatment option for patients with osteoarthritis (OA) of the knee. In accordance with the FDA’s standard 10-month review designation, the agency has established a user fee goal date under the Prescription Drug User Fee Act (PDUFA) of October 6, 2017.

“The FDA’s acceptance of the NDA for Zilretta is a seminal milestone for Flexion and encouraging news for the many millions of people who are confronting OA of the knee,” said Michael Clayman, president and chief executive of Flexion, adding: “The pain associated with OA of the knee can be debilitating, and we believe that, if approved, Zilretta could serve as an important new treatment option for patients suffering from this progressive condition.”

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