These data were published in the online Journal of the American Medical Association.
Fremanezumab is a monoclonal antibody that selectively targets CGRP (calcitonin gene-related peptide), a neuropeptide involved in the pathophysiology of migraine.
The study evaluated the use of both quarterly and monthly dosing regimens of subcutaneous fremanezumab, compared with placebo in patients with EM (defined as 14 migraine headache days or less per month) who had previously failed multiple medication classes.
The HALO EM trial met its primary endpoint demonstrating that fremanezumab significantly reduced monthly migraine days for both quarterly and monthly dosing regimens
The multicenter, randomized, double-blind, placebo-controlled, parallel-group study enrolled 875 patients and consisted of a screening visit, 28-day pre-treatment period, 12-week treatment period, and final evaluation at week 12.
The most common adverse events in patients treated with fremanezumab were injection site pain, induration, and erythema.
Fremanezumab is an investigational therapy currently under review by the US Food and Drug Administration as a quarterly or monthly injection for the preventive treatment of migraine in adults.
Teva is a patient-centric healthcare solutions, and generic and specialty medicines producer.
It leverages its portfolio of more than 1,800 molecules to produce a wide range of generic products in nearly every therapeutic area. In specialty medicines, the company has an innovative treatment for multiple sclerosis as well as late-stage development programmes for other disorders of the central nervous system, including movement disorders, migraine, pain and neurodegenerative conditions, as well as a broad portfolio of respiratory products.
Outlook Therapeutics receives positive CHMP opinion for ONS-5010 in wet AMD treatment
Oscotec receives ODD from FDA for Cevidoplenib
Human Immunology Biosciences receives ODD from FDA for felzartamab
Eton Pharmaceuticals acquires PKU GOLIKE, expanding rare disease portfolio
Vertex receives FDA clearance for VX-407 Investigational New Drug Application for ADPKD
TELA Bio launches LIQUIFIX for US hernia surgery
BD boosts US syringe production amid healthcare demand
Phanes Therapeutics receives FDA Fast Track designation for PT886
Bio-Thera Solutions signs new licensing agreement with SteinCares
FDA accepts resubmission of Citius Pharmaceuticals, Inc's BLA for LYMPHIR
GSK Plc reports positive Phase III Jemperli data for endometrial cancer
ImmVira receives FDA Fast Track designation for MVR-T3011 IT
Upgraded Syngene International biologics facility to start operation in 2024
BioXcel Therapeutics secures European patent for method to treat agitation in dementia