Novel FDA-approved zavegepant drug for treating migraine.

Migraine is a complex neurological disorder characterized by recurring episodes of severe headaches. The pathophysiology of migraine involves abnormalities in neuronal networks, cortical spreading depression, and sensitization of trigeminovascular pathways. The global prevalence of migraine has increased substantially, warranting advancements in treatment strategies. A significant trigger in migraine pathophysiology is calcitonin gene-related peptide (CGRP). Several drugs, such as gepants and monoclonal antibodies (MABs) targeting CGRP or its receptor, have been developed to antagonize CGRP signaling. Zavegepant (Zavzpret), a novel CGRP receptor antagonist, has recently been approved by the FDA for the acute treatment of migraine. Clinical trials have demonstrated its efficacy in providing headache and symptom relief, with a statistically significant percentage of patients achieving freedom from headaches and most bothersome symptoms. Despite mild adverse effects, such as taste disorders and nausea, Zavzpret's overall safety profile remains acceptable.

Briumvi: a breakthrough in the treatment of relapsing multiple sclerosis: a review.

Multiple sclerosis (MS) is a chronic systemic autoimmune disorder characterized by plaques of demyelination, autoimmune inflammation, and astrocytic gliosis. The primary cells involved in the pathophysiology of MS are T cells. However, B cells have recently been implicated in the pathophysiology of the disease. Therefore, researchers have been exploring B cell therapy as an alternative treatment option for MS. B cell therapy is based on the targeted depletion of CD20-positive B cells. Rituximab, ocrelizumab, and ofatumumab are anti-CD20 antibodies already approved. Briumvi, the fourth type of anti-CD20 antibody was approved by FDA in December 2022, for the treatment of relapsing types of MS, including relapsing-remitting multiple sclerosis, active secondary progressive multiple sclerosis, and clinically isolated syndromes after the drug was tested in two randomized, double-blind, phase III, ULTIMATE I, and II trials which compared Briumvi (ublituximab) with Aubiago (teriflunomide). Ublituximab was found to have a much lower annual relapse rate in the ULTIMATE II trials than teriflunomide. Briumvi is a chimeric recombinant IgG1 monoclonal antibody directed against human CD20 with potential antineoplastic activity. Its mechanism of action involves several distinct processes that collectively lead to the depletion of B cells and suppression of the immune response. The primary mode of action of Briumvi is its high-affinity binding to CD20. Infusion-related reactions are the most common side effects encountered following intravenous administration of ublituximab.