FDA to review application for granulated form of Ingrezza

Agency approved capsule form of the therapy for chorea last month

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by Steve Bryson, PhD |

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The U.S. Food and Drug Administration (FDA) will review Neurocrine Biosciences’ application of a new oral granule formulation of Ingrezza (valbenazine) for involuntary muscle contractions, or chorea, in adults with Huntington’s disease.

The therapy was recently approved in the U.S. for Huntington’s-associated chorea in the form of whole oral capsules. The new granule formulation is intended to be opened and sprinkled on soft foods.

Ingrezza is also FDA-approved for tardive dyskinesia, a disorder marked by uncontrolled movements of the face, torso, and/or other body parts.

“Patients with tardive dyskinesia or chorea associated with Huntington’s disease can experience dysphagia [swallowing difficulties] that can impact their ability to swallow capsules,” Eiry W. Roberts, MD, Neurocrine’s chief medical officer, said in a company press release. “We developed this potential new formulation of Ingrezza as an alternative administration option for those patients who have difficulty swallowing or simply prefer not to take whole capsules.”

The FDA’s decision on the new formulation is expected by April 30, 2024.

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How does Ingrezza work on Huntington’s chorea?

About 90% of adults with Huntington’s have chorea, which features uncontrolled, jerky movements that can affect coordination, walking, and posture, along with speech and swallowing.

Ingrezza, available in oral capsules at once daily doses of 40, 60, and 80 mg, is believed to prevent chorea by reducing the levels of dopamine, a signaling molecule. Its approval for Huntington’s-associated chorea was based mainly on the Phase 3 KINECT-HD clinical trial (NCT04102579). In the study, 128 adults with chorea took an oral capsule of Ingrezza or a placebo once daily for 12 weeks (about three months).

Ingrezza significantly reduced chorea severity compared with a placebo, as assessed with the Unified Huntington’s Disease Rating Scale-Total Maximal Chorea score. This measure evaluates chorea in the face, jaw, trunk, and limbs.

After three months, nearly half the patients on the therapy showed a reduction in chorea severity of more than 40%.

Those who completed KINECT-HD and other adults with Huntington’s-associated chorea were invited to enroll in an open-label extension study called KINECT-HD2 (NCT04400331), where they are receiving the therapy for up to three years.

According to Neurocrine, the regulatory application for Ingrezza’s new oral granule formulation (available in 40, 60, and 80 mg capsules) is supported by data that shows an efficacy and tolerability that’s similar to the whole capsules.

The company has provided the FDA with information on chemistry, as well as manufacturing and controls data, a process to ensure the quality and consistency of drug manufacturing. The FDA granted Ingrezza orphan drug status last year for Huntington’s-associated chorea, a designation meant to expedite its development and regulatory review.