NeurologyLive® Year in Review 2021: FDA Stories

Similar to the last few years, 2021 has been a major year for progress in the therapeutic realm for neurologic diseases. From sleep disorders to migraine to neuromuscular diseases and beyond, the FDA has approved numerous new treatments to address unmet needs in a range of disorders, including a landmark decision in Alzheimer disease, among others

FDA actions are a foundational part of the NeurologyLive^® team's coverage each year, as many of these approvals marked important moments for a number of patient populations and their health care professionals. Any addition to the therapeutic landscape of a disease is a welcome sign, as each new therapy provides a new approach to care.

Look back on some of the FDA approvals in 2021 by clicking the buttons below:

EEG Wearable Device System FDA Approved for Epilepsy

Neuronaute consists of a smart shirt and smart cap containing biosensors that monitor physiological characteristics, such as muscle activity and heart and respiratory rate.

FDA Clears First Rapid Traumatic Brain Injury Blood Test

Having a blood test available could help eliminate wait time in the emergency room and could reduce the number of unnecessary CT scans by up to 40%, according to Abbott, the test’s developer.

FDA Approves Boston Scientific’s Vercise Genus DBS System for Use in MRI Environment

This fourth-generation system since 2012 is indicated as adjunctive therapy for stimulation of the subthalamic nucleus and internal globus pallidus to treat Parkinson symptoms.

FDA Approves Nerivio Migraine Device for Adolescents

After winning FDA approval in October 2020, the new expanded indication includes adolescents aged 12 and older with episodic or chronic migraine.

FDA Authorizes Novel eXciteOSA Device to Reduce Snoring, Mild Sleep Apnea

The eXciteOSA device is a daytime therapy that uniquely targets the root cause of snoring and mild obstructive sleep apnea by using electrical currents to stimulate and improve muscle function in the mouth and tongue.

OnabotulinumtoxinA Approved for Pediatric Neurogenic Detrusor Overactivity

The treatment can be used in children aged 5 years or older that are intolerant of or do not respond well to anticholinergic medication.

FDA Approves MRI Labeling for Genio Obstructive Sleep Apnea Therapy

The Genio system offers bilateral stimulation of the hypoglossal nerve branches, which may lead to potentially greater airway opening for patients with obstructive sleep apnea.

GammaCore Gets Expanded Indication for Preventive Treatment of Adolescent Migraine

ElectroCore announced that the expanded indication, noting that gammaCore is now the only acute and preventive option approved for both adult and adolescent migraine.

Sarepta’s Casimersen Approved for DMD Amenable to Exon 45 Skipping

The antisense oligonucleotide casimersen will be branded as Amondys 45 and is currently being assessed in the ESSENCE phase 3 clinical trial (NCT02500381).

Relivion Noninvasive Neuromodulation System Cleared for Acute Migraine

The headset system from Neurolief was approved based on the findings of a clinical trial of 131 patients with migraine who utilized the device in treatment sessions of up to 1 hour.

FDA Clears Pediatric Version of NeuroCap EEG Headset

The disposable NeuroCap allows for minimal chances of flawed EEG due to all of the contact points between scalp and electrode sensors being pre-gelled.

Ponesimod Gets OK for Relapsing Multiple Sclerosis

The oral S1P1 modulator joins a number of other agents in its class, and has also been submitted to the European Medicines Agency for approval in the treatment of MS.

Mirabegron Extended-Release Tablets, Oral Suspension Approved for Neurogenic Detrusor Overactivity

The Astellas Pharma agent earned an indication for children aged 3 years and older, after its original overactive bladder indication in 2012.

Portable Neuromodulation Stimulator Device for MS Gait Deficit Wins Approval

The PoNS device becomes the first and only medical device cleared in the US for short-term treatment of gait in patients with multiple sclerosis.

FDA Authorizes Neurolutions’ IpsiHand Stroke Rehab System

The Neurolutions IpsiHand Upper Extremity Rehabilitation system is indicated for use in patients with chronic stroke age 18 or older undergoing stroke rehabilitation to facilitate muscle re-education.

Rimegepant Approved for Preventive Treatment of Migraine, Adding to Acute Indication

Biohaven’s agent is now the first oral CGRP antagonist to be approved for prevention, and the first to be approved for both acute and preventive therapy. It is marketed as Nurtec ODT and is administered in a 75-mg dose.

Aducanumab Approved for Alzheimer Disease Treatment

The FDA has approved Biogen’s disease-modifying, anti-amyloid agent aducanumab after a tumultuous regulatory journey.

SenSight Directional Lead System Approved for DBS Therapy

When paired with the Percept PC device, SenSight expands on BrainSense technology, enabling clinicians to capture and record enhanced, directional local field potential information from the implanted lead.

Dabigatran Etexilate Wins Approval for Pediatric Venous Thromboembolism

The blood-thinning therapy was approved in both oral pellet and capsule forms for varying pediatric populations.

FDA Approves Senza System for Chronic Pain Associated With Diabetic Neuropathy

Basis for the approval was the SENZA-PDN randomized controlled trial, which showed the system’s ability to substantially sustain pain relief and improve health-related quality of life.

FDA Approves Xywav for Idiopathic Hypersomnia

After years of only off-label, wake-promoting therapies available for use, the FDA has approved the first treatment for idiopathic hypersomnia, JZP-258 (Xywav; Jazz).

FDA Approves Vivistim VNS System for Ischemic Stroke Motor Deficits

MicroTransponder’s system is the first of its kind to be granted this indication, after supporting data from the VNS-REHAB trial suggested its efficacy in improving FMA-UE scores.

FDA Approves Brivaracetam for Partial-Onset Seizures in Pediatric Epilepsy

After receiving original approval in 2016, brivaracetam is now available as both monotherapy or adjunctive therapy to treat partial-onset seizures in pediatrics 1 month of age and older.

Acute Migraine Treatment INP104 Approved

Impel’s agent is designed to deliver a lower dose of dihydroergotamine mesylate (DHE) compared with other nasally administered products.

Atogepant Approved for Episodic Migraine Prevention

The gepant, marketed as Qulipta, is the first oral calcitonin gene-related peptide receptor antagonist approved for episodic migraine.

FDA Approves First Oral Solution of Topiramate to Treat Epilepsy, Migraines

Originally approved in 1996, the therapy, indicated for the treatment of to partial-onset and tonic clonic seizures, is now available in a liquid formulation.