FDA approves label change for Flexion's Zilretta

4 January 2020

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The US Food and Drug Administration has approved a supplemental New Drug Application (sNDA) to update the product label for Zilretta (triamcinolone acetonide extended-release injectable suspension) for the treatment of osteoarthritis (OA) knee pain.

The news pushed up the shares of Flexion Therapeutics (Nasdaq: FLXN), which markets the drug, by 14%, meaning the stock has now doubled from its lows this summer. The drug was first approved by the FDA in October 2017 and generated sales of $21.8 million in third-quarter 2019.

Key elements of the label update include:

Removal of language which stated that Zilretta was “not intended for repeat administration.” The updated label states that the “efficacy and safety of repeat administration of Zilretta have not been demonstrated.”
Inclusion of a study description and safety data from the single-arm, open-label Phase III repeat administration trial.
Removal of a misleading statement describing a single secondary exploratory endpoint in the original Phase III pivotal trial which compared Zilretta to immediate release triamcinolone acetonide crystalline suspension.
Inclusion of non-clinical toxicology data from previously-submitted single and repeat administration studies in non-diseased animals.

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