US FDA approves Neurocrine Biosciences' movement disorder drug
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[May 02, 2024]
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 disorder tardive dyskinesia.
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.
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 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
billion 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.
(Reporting by Sruthi Narasimha Chari and Mariam Sunny in Bengaluru;
Editing by Alan Barona)
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