April 30 (Reuters) - The U.S. Food and Drug
Administration (FDA) has approved the granule formulation of
Neurocrine Biosciences' ( NBIX ) 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'
Austedo 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.