Neurocrine's Ingrezza garners FDA approval

Neurocrine Biosciences announced on Tuesday that the FDA has sanctioned an oral granule form of its VMAT2 inhibitor, Ingrezza (valbenazine), specifically for patients with tardive dyskinesia (TD) and chorea associated with Huntington's disease (HD) who struggle with swallowing. Instead of adhering to a once-daily pill regimen, patients now have the option to sprinkle the contents of a daily Ingrezza capsule onto soft food as an alternative means of oral administration.

A survey conducted by Neurocrine revealed that approximately 62% of HD patients with chorea and their caregivers experience difficulty with swallowing. Similarly, 37% of TD patients report that their moderate-to-severe involuntary movements significantly impact their ability to eat and drink. The new granule formulation addresses these challenges, offering a more accessible treatment option for those affected.

Ingrezza initially received FDA approval as a pill for treating TD in 2017 and later for HD patients with chorea in 2023. The recent approval for the granule form was based on data demonstrating that this sprinkled version is bioequivalent to the capsule form, exhibiting similar tolerability.

This regulatory approval marks another achievement for Neurocrine Biosciences. Recently, the company's experimental treatment for major depressive disorder (MDD) successfully met the primary and key secondary endpoints in a Phase II study, further solidifying Neurocrine's growing reputation in the biopharmaceutical industry.