Vutrisiran FDA Decision Extended, Gamma Sensory Stimulation Shows Benefit in Alzheimer, DBS Programming Software Greenlit


Neurology News Network for the week ending April 16, 2022 [WATCH TIME: 3 minutes]

WATCH TIME: 3 minutes

Welcome to this special edition of Neurology News Network. I’m Marco Meglio.

Vutrisiran, an investigational subcutaneous RNA interface (RNAi) therapy in development for the treatment of transthyretin-mediated (ATTR) amyloidosis—both hereditary (hATTR) and wild-type—has had its FDA review period extended 3 months. The Alnylam product’s new drug application (NDA) now has a target review date of July 14, 2022.Importantly, there are no additional clinical data requests from the FDA. In a statement, Alnylam announced that this extension on the review period has been offered to allow for the appraisal of new information related to a secondary packaging and labeling facility that had recently been inspected and needed classification for the FDA to complete its review, with no issues directly related to vutrisiran. Alnylam noted that it had identified a new facility for those processes and submitted an amendment to the NDA as a result. The Alnylam product was granted fast track designation by the FDA for the treatment of polyneuropathy related to hATTR amyloidosis in April 2020, shortly after completing enrollment for its phase 3 HELIOS-A study.

After preliminary results from the phase 2 OVERTURE study confirmed the safety of Cognito Therapeutics’ at-home gamma sensory stimulation device in patients with Alzheimer disease (AD), new data have uncovered more about the cognitive and functional benefits patients receive from this therapy.At 6 months, patients treated with the noninvasive, visual and auditory gamma (40 hz) sensory stimulation demonstrated significantly better changes in Alzheimer’s Disease Cooperative Study–Activities of Daily Living (ADCS-ADL) scores compared with those on sham, indicating a 78% slowing in functional decline (<.0003). The results, presented at the 2022 American Academy of Neurology (AAN) Annual Meeting, April 2-7, in Seattle, Washington, also showed that the treatment has potential disease-modifying effects, indicated by reductions in brain atrophy. In addition to showing better results on ADCS-ADL than placebo, patients treated with gamma sensory stimulation showed a statistically significant 83% (<.013) reduction in cognitive decline, represented by scores on Mini-Mental State Examination.

The FDA has approved Boston Scientific’s STIMVIEW XT guided programming software, which allows clinicians to visualize in real-time both lead placement and stimulation modeling of brain anatomy for patients with Parkinson disease (PD) or essential tremor who undergo deep brain stimulation. STIMVIEW XT is used in conjunction with the Vercise Genus DBS System, Boston Scientific’s patented product that received FDA approval in 2021. Using patient-specific 3D visualization, STIMVIEW XT empowers DBS programmers to optimize and deliver directional stimulation more efficiently. The Vercise system consists of a group of Bluetooth-enabled implantable pulse generators (IPGs) that power Cartesia Directional leads, designed to provide optimal symptom relief. It is the fourth generation of the DBS system since released in 2012, developed to build on the ongoing innovations being made in battery longevity, directionality, and stimulation capabilities.

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