Roberts: Ingrezza is chorea treatment that’s easier to take
Neurocrine CMO calls capsule a 'convenient solution' for Huntington's patients
The recent approval in the U.S. of Ingrezza (valbenazine) for adults with Huntington’s disease-associated chorea means patients now have access to a treatment option that’s likely easier to take, according to the chief medical officer of Neurocrine Biosciences, the therapy’s maker.
“Ingrezza is always one capsule, once daily,” Eiry W. Roberts, MD, said in a written Q&A with Huntington’s Disease News. “Unlike other available treatment options for [Huntington’s disease] chorea, which may require complex dose adjustments to either multiple daily doses or multiple different pills, the ease of use of Ingrezza with one capsule, once-daily dosing provides a convenient treatment option for patients.”
Involuntary jerking and writhing movements known as chorea are a hallmark of Huntington’s, affecting about 90% of patients. It can affect coordination, walking, posture, swallowing, and speech.
INBRACE for prescription assistance
Neurocrine offers INBRACE, a support program that “helps patients who are prescribed Ingrezza by assisting with product support and prescription fulfillment through a dedicated network of specialty and local affiliated pharmacies,” Roberts said.
It includes copay assistance for eligible commercially insured patients, as well as support for those without coverage who can’t afford their medication.
Coverage for Ingrezza is approved for more than 80% of Huntington’s chorea patients in the U.S. regardless of insurance, and “most patients pay less than $10 for Ingrezza,” Robert said. “Many people living with HD chorea who are enrolled in Medicare and Medicaid have dual-eligible status, meaning they often have low to no premiums and copayments.”
The program can be reached at 1-84-INGREZZA (1-844-647-3992) from 8 a.m. to 8 p.m. EST, Monday-Friday, or by visiting its website.
“At Neurocrine Biosciences, we are committed to fulfilling unmet medical needs for debilitating neurological diseases, and we recognize the profound impact chorea can have on the daily lives of people living with HD as well as their caregivers,” Roberts said.
Advantage of Ingrezza as treatment for chorea
Ingrezza is available in oral capsules of three dosage strengths — 40, 60, and 80 mg. It’s recommended that patients start at 40 mg/day, then increase to 60 mg/day after two weeks before taking 80 mg/day after another two weeks. Lower maintenance doses of one 40 or 60 mg capsule a day may be considered, based on a patient’s response and tolerability.
This means patients only ever have to take one capsule a day, which is a notable advantage relative to other approved chorea treatments like Xenazine (tetrabenazine) and Austedo (deutetrabenazine), according to Roberts.
Ingrezza’s approval for chorea was mainly supported by data from the Phase 3 KINECT-HD clinical trial (NCT04102579), which enrolled 128 adults with Huntington’s-related chorea. Participants were given either Ingrezza or a placebo once a day for about three months.
The study’s main goal was to assess the impact of treatment on chorea severity in the face, jaw, trunk, and limbs, as measured by the Total Maximal Chorea (TMC) score of the Unified Huntington’s Disease Rating Scale.
TMC scores improved by 4.6 points after three months with Ingrezza, compared with just 1.4 points with a placebo — a more than 3 point difference that was statistically significant.
After three months of treatment, nearly half the patients in the Ingrezza group saw a reduction in chorea severity of more than 40%.
Most patients treated with Ingrezza saw an improvement in TMC score of at least 1 point within two weeks of starting the therapy, according to Roberts.
Also, considerable improvements in overall health were two to three times more common in the Ingrezza group than in the placebo group.
Along with these well-established measures, KINECT-HD was the first Phase 3 trial to use the Huntington’s Disease Health Index (HD-HI), a new patient-reported assessment designed to measure how specific aspects of Huntington’s respond to therapy.
Compared with those on a placebo, patients given Ingrezza reported greater gains on eight of the 13 HD-HI domains, Roberts noted.
“Greater improvements were seen in mobility, abnormal movements and hand and arm function, which are categories that particularly affect people with HD chorea,” Roberts said. “Other categories where improvement was seen included cognition, emotional health, social performance, social satisfaction, and gastrointestinal health/swallowing function.”
Ingrezza side effects
Common side effects included sleepiness, hives, rash, and difficulty getting to sleep or staying asleep.
Like Xenazine and Austedo, which also work by blocking the activity of the VMAT2 protein, Ingrezza’s label warns of an increased risk of depression and suicidal thoughts.
“As with any medication, it’s important for people to be aware of potential side effects,” Roberts said. “People with HD have a higher risk of depression and suicidal thoughts or actions, so it’s important that they speak with their healthcare provider to determine if treatment with Ingrezza is right for them. The healthcare provider will need to balance the risks and benefits of treatment specific to each patient.”
People taking Ingrezza should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when Ingrezza is started and when the dose is changed.
Patients should talk to their healthcare provider if they have any history of depression or suicidal thoughts, she said.
“People taking Ingrezza should pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is especially important when Ingrezza is started and when the dose is changed,” Roberts said, noting the changes should prompt a healthcare provider to be contacted immediately.
“We are proud to provide Ingrezza as a new treatment option to those living with the challenging effects of HD chorea, and we are hopeful that the introduction of Ingrezza ignites more conversations between healthcare providers, patients, and caregivers about how chorea may be impacting daily activities to determine if treatment is appropriate,” Roberts said.
New formulation under review
A new oral granule formulation of Ingrezza is being reviewed by the U.S. Food and Drug Administration (FDA) for Huntington’s-associated chorea. A decision is expected in April.
“The Ingrezza oral granules capsules are intended to be opened for sprinkling oral granules on soft foods prior to administration,” Roberts said. “This potential new formulation of Ingrezza is an alternative administration option for patients who have difficulty swallowing or prefer not to swallow whole capsules including patients living with HD chorea.”
Neurocrine has no immediate plans to commercialize Ingrezza outside the U.S., Roberts said.
“We will continue to keep the community updated on any potential global clinical development and commercialization plans,” she said.
Ingrezza is also FDA-approved for tardive dyskinesia, a disorder marked by uncontrolled movements of the face, torso, and/or other body parts.
About the Author
