COVID-19 Vaccine and Potential Stroke Concern, Associations Between AEDs and Incident Parkinson, FDA Accepts sBLA for DaxibolinumtoxinA

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

Recently, the FDA and Centers for Disease Control and Prevention (CDC) issued a joint statement claiming that the agencies were assessing data regarding Pfizer-BioNTech's COVID-19 vaccine bivalent increases the risk of ischemic stroke in elders. "CDC’s Vaccine Safety Datalink (VSD), a near real-time surveillance system, met the statistical criteria to prompt additional investigation into whether there was a safety concern for ischemic stroke in people ages 65 and older who received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent," the CDC/FDA statement read. "Rapid-response investigation of the signal in the VSD raised a question of whether people 65 and older who have received the Pfizer-BioNTech COVID-19 Vaccine, Bivalent were more likely to have an ischemic stroke in the 21 days following vaccination compared with days 22-42 following vaccination." On the CDC website, they also said government agencies use various monitoring systems to detect possible safety signals for vaccines. They will investigate further when appropriate. “Often these safety systems detect signals that could be due to factors other than the vaccine itself,” the website read.

Using data from the UK Biobank (UKB), recently published research found an association between antiepileptic drug (AED) prescription use and incident Parkinson disease (PD) diagnosis. These findings were consistent with previous reports of an association between epilepsy and PD. Data extracted in June 2021 showed an association between AED use and incident PD, as explained by ORs of 1.80. Specifically, sodium valproate showed the highest OR, followed by levetiracetam, lamotrigine, and carbamazepine. The odds of incident PD were higher among individuals prescribed more than 1 AED and among individuals with higher number of issues.

After showing positive results in a phase 3 clinical program, the FDA has accepted Revance Therapeutic’s supplemental new biologics license application (sBLA) for daxibotulinumtoxinA injection (Daxxify), as a new treatment for adults with cervical dystonia. The agency scheduled August 19, 2023, as the PDUFA date for the therapy. To date, the therapy has shown promising results in 2 phase 3 studies of cervical dystonia, ASPEN-1 and ASPEN-OLS. In ASPEN-1, both the 125- and 250-unit dose groups of daxibotulinumtoxinA met the primary end point of clinically meaningful improvement in the signs and symptoms of cervical dystonia, on average, by weeks 4 and 6. In this randomized, placebo-controlled, parallel group study, the 125- and 250-unit treatment groups showed improvements of 12.7 and 10.9 points, respectively, on Toronto Western Spasmodic Torticollis Rating Scale (TWSTRS) vs the placebo group, which recorded changes of 4.3.

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