AbbVie Submits NDA for ABBV-951, Periconceptional Folic Acid Supplementation Lowers Preterm Birth Risk, FDA Accepts NDA for Zavegepant


Neurology News Network for the week ending May 28, 2022.

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

AbbVie has submitted a new drug application (NDA) for its investigational agent ABBV-951, a continuous 24-hour subcutaneous infusion of foslevodopa/foscarbidopa, for the treatment of motor fluctuations in patients with advanced Parkinson disease (PD).For years, the combination of levodopa and carbidopa (LD/CD) has been the standard of care for symptom management in patients with PD. If approved, ABBV-951 will become the first subcutaneous delivery of the therapy, representing a potentially landscape-altering treatment option. The NDA is based on the phase 3 M15-736 study (NCT04380142), a double-blind, double-dummy trial in which treatment with the agent resulted in increased ON time by 2.72 hours over a 12-week period compared to 0.97 hours for oral LD/CD. These improvements, documented using the Parkinson’s Disease Diary, were observed as early as the first week and persisted through the end of the study period.

Findings from the prospective Norwegian Mother and Child Cohort Study (MoBA) showed that among women with epilepsy on an antiseizure medication (ASM), periconceptional folic acid supplementation was associated with a lower risk of preterm birth. All told, there was a 3-fold increase in the risk among those who did not undergo supplementation vs those who did.Among those with epilepsy on an ASM, the mean gestational age at birth was 279 days (SD, 11.8) in pregnancies with periconceptional folic acid supplementation, compared with 272 days (SD, 19.8) for those without periconceptional folic acid (<.001). In contrast, the mean gestational age at birth was similar in those with epilepsy without ASM and those without epilepsy, regardless of folic acid supplementation. In total, 5% of the pregnancies among those with epilepsy with an ASM resulted in preterm birth for the mothers who had used folic acid supplementation periconceptionally, compared with 14% when they had not.

The FDA has filed and accepted a new drug application for Biohaven’s calcitonin gene-related peptide (CGRP) receptor antagonist, zavegepant, for the acute treatment of migraine, with a Prescription Drug User Fee Act action date set for Q1 2023. If approved, zavegepant nasal spray would be the only FDA-approved medication to target CGRP in an intranasal formulation, giving patients a new treatment option that provides ultra-rapid pain relief.Zavegepant, a third generation, high affinity, selective and structurally unique agent, had its NDA backed by 2 pivotal double-blind, placebo-controlled studies. In both trials, zavegepant demonstrated statistically significant differences in comparison to placebo on the coprimary regulatory end points of superiority at 2 hours for pain freedom and freedom from the most bothersome symptom. The first study (BHV3500-201; NCT03872453), evaluated zavegepant in forms of 5-, 10-, and 20-mg doses vs placebo in 1673 patients with migraine. In addition to meeting the coprimary end points, the agent demonstrated a duration and sustained effect profile through 48 hours (nominal <.05). This included sustained pain freedom 2 to 24 hours,, sustained pain freedom 2 to 48 hours, sustained pain relief 2 to 24 hours, and sustained pain relief 2 to 48 hours.

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