FDA Approves Ingrezza for Disorder Associated with Huntington’s Disease
In addition to tardive dyskinesia, Ingrezza now also treats chorea associated with Huntington’s disease, which is a movement disorder that effects coordination, gait, swallowing and speech.
The FDA has approved Ingrezza (valbenazine) capsules to treat adults with chorea associated with Huntington’s disease (HD), a hereditary progressive neurodegenerative disorder. Most people with Huntington’s disease experience chorea, an involuntary movement disorder that is characterized by irregular and unpredictable movements. It can affect various body parts and interfere with motor coordination, gait, swallowing and speech. Huntington’s disease is estimated to affect about 41,000 adults in the United States.
Developed by Neurocrine Biosciences, Ingrezza is a once-daily selective vesicular monoamine transporter 2 (VMAT2) inhibitor. It is believed to reduce extra dopamine signaling, which may lead to fewer uncontrollable movements. Ingrezza is also approved to treat tardive dyskinesia. It has a list price of $8,457 for a supply of 28 capsules, according to Drugs.com. A spokesperson said the new approval will not effects its price.
Ingrezza is currently available through a network of specialty and local affiliated pharmacies. These include Amber Specialty Pharmacy, CVS Specialty Pharmacy, Orsini Specialty, PANTHERx Rare, AllianceRx Walgreens Pharmacy and Genoa Healthcare Pharmacy.
Ingrezza is covered for more than eight out of 10 patients nationwide, according to a Neurocrine spokesperson. The company's Inbrace support program helps patients with access. Patients with commercial insurance may be eligible for copay assistance and patients with no prescription coverage who also lack the financial resources to pay for their medicine may be eligible for participation in the patient assistance program.
Louise Vetter
“Chorea associated with HD can significantly affect the quality of life of a person living with HD by impacting their daily activities, social life, independence and overall well-being,” said Louise Vetter, president and CEO of the Huntington’s Disease Society of America, said in a press release.
The FDA approval for chorea is supported by data from two clinical studies conducted in collaboration with the Huntington Study Group (HSG), including the KINECT-HD phase 3 study and the ongoing KINEC-HD2 open-label extension trial.
The KINECT-HD trial showed that Ingrezza resulted in statistically significant greater improvement in chorea severity using the Total Maximal Chorea (TMC). Ingrezza demonstrated a three-times greater improvement in chorea severity compared with placebo, and almost half of patients saw a reduced chorea severity by about 40% from baseline. Results were published in June 2023 in The Lancet Neurology.
The prescribing information for Ingrezza now includes safety information about serious risk of depression and suicidal ideation and behavior in patients with Huntington’s disease and Neuroleptic Malignant Syndrome (NMS).
This story was updated to include additional information from Neurocrine Biosciences.
In this episode of the "Meet the Board" podcast series, Briana Contreras, Managed Healthcare Executive editor, speaks with Ateev Mehrotra, a member of the MHE editorial advisory board and a professor of healthcare policy and medicine at Harvard Medical School. Mehtrotra is also a hospitalist at the Beth Israel Deaconess Medical Center in Boston. In the discussion, Contreras gets to know Mehrotra more on a personal level and picks his brain on some of his research interests including telehealth, alternative payment models and price transparency.
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