Positive phase III data for Neurocrine’s Ingrezza in Huntington’s disease

Neurocrine Biosciences has recently announced that its pipeline asset, Ingrezza (valbenazine), achieved the primary endpoint of reducing the symptoms of chorea (involuntary muscle movements) associated with Huntington’s disease (HD) in the Phase III clinical trial, KINECT-HD (NCT04102579). This will propel Ingrezza into a dominant position in the HD market, due to its convenient once-daily dosing regimen and improved safety profile, according to GlobalData, a data and analytics company.

GlobalData’s report, ‘GlobalData (2021) Huntington’s Disease: Opportunity Assessment and Forecast to 2030’, reveals that given Ingrezza’s competitive advantage and the sparseness of the US HD therapeutics market, it is set to generate strong sales of $326m for HD in the US through 2030*.

Compared to available competitors within the same therapeutic class, Ingrezza requires less-frequent dosing and does not pose the risk of increasing depression and suicidality. This is a key advantage, as the development of psychiatric and cognitive symptoms is a common comorbidity in HD patients.”

Sarah Elsayed, Neurology Analyst at GlobalData

Neurocrine plans to submit a supplemental new drug application in HD chorea, meaning that the drug could be available for HD patients in the US by Q1 2023. Key opinion leaders (KOLs) previously interviewed by GlobalData highlighted that one of the most pressing unmet needs in HD is for improved symptomatic treatments that can demonstrate superior clinical efficacy and/or safety to the current standard of care.

Chorea occurs in over 80% of patients with adult-onset HD and is not effectively managed by current treatment options. Thus, KOLs believed that Ingrezza will be a welcome addition to the HD armamentarium and will fulfill a key unmet need.”

Sarah Elsayed, Neurology Analyst at GlobalData

Currently, there are only two drugs approved in the US for the treatment of chorea associated with HD: Bausch’s Xenazine (tetrabenazine) and Teva’s Austedo. Additionally, several generic versions exist for tetrabenazine in the US, offering comparable efficacy at lower costs.

Elsayed continues: “That said, tetrabenazine generics may not be preferred by many patients as they require dosing three times per day and have a boxed warning on the label regarding the increased risk of suicidality. These issues directly affect patient compliance and subsequently limit the utility of those treatments. Ingrezza is therefore more likely to compete for new patients against Teva’s Austedo, which has been widely adopted by physicians since its launch in 2017, owing to the convenience of its twice-daily dosing. However, like tetrabenazine, Austedo also has a boxed a warning regarding the risks of depression and suicidality.”

GlobalData believes that the clinical advantages Ingrezza has shown so far in trials will allow it to move to the front lines of treatment for HD chorea and gain significant market share upon launch in the US.”

Sarah Elsayed, Neurology Analyst at GlobalData