Fumarate Bioequivalent for MS, Embrace Smartband Approval, Alzheimer Biomarkers Identified, Long-Term Perampanel Data

This week Neurology News Network covered the tentative approval granted by the FDA for Banner Life Sciences' NDA for a novel fumarate bioequivalent alternative for dimethyl fumarate as a treatment for relapsing multiple sclerosis, Empatica's Embrace smartband that was granted 510(k) device clearance by the FDA for use with pediatric patients with epilepsy aged 6 years and older, and new research that has identified a trio of biomarkers for detection of both mild cognitive impairment and Alzheimer disease in saliva samples. We also shared a clip from a recent conversation with Trevor Resnick, MD, pediatric epileptologist at Nicklaus Children's Hospital, who spoke about the encouraging results from the long-term seizure freedom data on perampanel that demonstrated its clinical impact for patients with secondarily generalized seizures. (Transcript below.)

Jenna:

Welcome to Neurology News Network. I’m Jenna.

Matt:

And I'm Matt Hoffman. Let’s get into the news from this week.

This week, Banner Life Sciences announced that on the FDA has granted tentative approval of its NDA for a novel fumarate bioequivalent alternative for dimethyl fumarate as a treatment for relapsing multiple sclerosis.

The novel therapy is being marketed as Bafiertam, and final approval is expected by June 20, 2020, ahead of the generic erosion following the patent expiration of Biogen’s Tecfidera. The FDA letter to Banner stated that Bafiertam meets the qualifications for the required bioequivalence, safety, efficacy, and quality standards for approval.

Jenna:

The FDA also granted 510(k) device clearance to Empatica for its Embrace smartband for use with pediatric patients with epilepsy aged 6 years and older.

The smartband, previously approved for use in adults with epilepsy in February 2018, uses pattern detection to pick up on movement and physiological signatures indicating the occurrence of generalized tonic-clonic seizures. When it picks up the signature, it alerts caregivers with the information. In a clinical trial of 141 patients with epilepsy within an Epilepsy Monitoring Unit, including 80 pediatric patients aged 6 to 21 years, the smartband detected seizures with 98% accuracy. Ultimately, it identified 53 out of 54 generalized tonic-clonic seizures.

Matt:

New research has identified a trio of biomarkers for the detection of both mild cognitive impairment and Alzheimer disease in saliva samples, with the results suggesting a promising potential for clinical application.

Ultimately, the research group from the University of Alberta used mass spectrometry to examine more than 6000 metabolites from biomarker panels tailored to the discrimination of those who were cognitively normal, those with MCI, and those with Alzheimer, seeking distinct signatures between groups.

The researchers noted that if a larger set of samples can be used to test the 3 metabolites identified, they can validate the findings and develop a saliva test for Alzheimer disease.

Jenna:

In a conversation with NeurologyLive, Trevor Resnick, MD, pediatric epileptologist at Nicklaus Children’s Hospital, spoke about the encouraging results from the long-term seizure freedom data on perampanel that demonstrated its clinical impact for patients with secondarily generalized seizures. Let’s take a look.

For more direct access to expert insight, head to neurologylive.com. This has been Neurology News Network. Thanks for watching.