Neurocrine Biosciences’ Huntington’s disease drug gets FDA approval

By Thomson Reuters Apr 30, 2024 | 4:32 PM

By Sruthi Narasimha Chari

(Reuters) -The U.S. Food and Drug Administration (FDA) has approved the granule formulation of Neurocrine Biosciences’ Ingrezza drug to treat movement disorders associated with Huntington’s disease (HD), the company said on Tuesday.

Huntington’s disease is an inherited condition that causes the progressive breakdown of nerve cells in the brain, resulting in a gradual decline in motor control, cognition and mental stability.

Ingrezza was first approved in 2017 in its oral capsule formulation to treat adults with movement disorders tardive dyskinesia and chorea.

The granule formulation, Ingrezza Sprinkle, was developed as an alternative for patients with tardive dyskinesia and chorea who face difficulty swallowing capsules.

The company did not immediately respond to a Reuters request seeking details on the drug’s availability and pricing.

Tardive dyskinesia is a medication-induced movement disorder characterized by uncontrollable movements of the face, torso and/or other body parts.

Chorea associated with HD is a movement disorder that can interfere with swallowing and speech, among other bodily functions.

The approval was based on positive data demonstrating the equivalence and tolerability of Ingrezza granules compared with the currently approved capsule version.

Ingrezza oral granules, available under three dosages – 40 mg, 60 mg and 80 mg – are to be sprinkled on soft foods prior to administration.

TD Cowen analyst Phil Nadeau said Ingrezza could achieve $3.2 bln in U.S. sales in tardive dyskinesia by 2028.

Nadeau estimates that the drug has only been adopted by about 30,000 patients, indicating significant growth potential for Ingrezza.

Israel-based Teva Pharmaceutical Industries’ Austdedo is also approved to treat chorea stemming from Huntington’s disease.

Ingrezza recorded global sales of $1.84 billion in 2023 and the company expects the drug to generate overall sales in the range of $2.1 billion to $2.2 billion this year.

(Reporting by Sruthi Narasimha Chari and Mariam Sunny in Bengaluru; Editing by Alan Barona)