08:38 AM EDT, 09/10/2024 (MT Newswires) -- Arrowhead Pharmaceuticals ( ARWR ) said Tuesday that the US Food and Drug Administration has granted breakthrough therapy designation to plozasiran as an adjunct treatment for adults with familial chylomicronemia syndrome.

The designation is intended to expedite the development and review of drugs that treat a serious condition and that may demonstrate substantial improvement over available therapies.

Arrowhead said it plans to submit a new drug application to the FDA by the end of the year and that it will seek regulatory approval with international regulatory authorities afterward.

The FDA has already granted plozasiran fast-track designation, while the European Medicines Agency previously granted it orphan-drug designation.

Shares of Arrowhead were up nearly 3% in recent premarket activity.

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