FDA Approves Novartis and Amgen's Innovative Migraine Treatment
Discover how Novartis and Amgen's newly FDA-approved migraine medication offers a groundbreaking preventive solution, with availability in the U.S. imminent.
Novartis AG (ADR) (NVS) proudly announces that the U.S. Food and Drug Administration (FDA) has officially approved Aimovig (erenumab) as a preventive therapy for adult migraine sufferers. This milestone marks a significant advancement in migraine management. (Also explore: The Rising Impact of Migraine Medications.)
Effective Prevention Cuts Migraine Frequency and Medication Dependence
Aimovig targets the calcitonin gene-related peptide receptor (CGRP-R), a key factor implicated in migraine development. Designed for convenient self-administration, the medication is delivered monthly through Amgen Inc.’s (AMGN) user-friendly SureClick auto-injector, available in 70 mg and 140 mg doses.
Extensive phase 2 and phase 3 clinical trials involving patients with both chronic and episodic migraine demonstrated that Aimovig significantly reduces the number of monthly migraine days. These days represent periods of intense headache episodes. Compared to placebo, Aimovig also notably lowers the reliance on acute migraine medications, enhancing patient quality of life.
With a robust safety, efficacy, and tolerability profile confirmed in over 3,000 participants, Aimovig has shown exceptional results, especially among patients with challenging-to-treat episodic migraines who previously failed multiple therapies. In this group, the 140 mg dose nearly tripled the likelihood of halving migraine days compared to placebo.
Paul Hudson, CEO of Novartis Pharmaceuticals, emphasized, "The FDA’s approval of Aimovig underscores our dedication to delivering transformative treatments for complex neurological conditions like migraine. As the first therapy targeting the CGRP receptor, Aimovig offers hope to millions, helping them reclaim lost days each month."
Migraine remains a debilitating neurological disorder affecting millions across the United States, characterized by severe headaches and associated symptoms.
Novartis and Amgen have also launched the "Aimovig Ally Product Support Program," designed to assist patients in securing insurance coverage and accessing vital resources for those uninsured or underinsured.
Priced at $575 per monthly dose (70 mg or 140 mg) via prefilled SureClick auto-injectors, the annual cost approximates $6,900. Aimovig is expected to be available in the U.S. market within one week.
Meanwhile, Novartis anticipates receiving European Medicines Agency (EMA) approval for Aimovig in the near future, expanding access to this innovative therapy across the EU.
At pre-market trading, Novartis shares were valued at $77.48, with Amgen shares at $177.01. (Also read: Collaborative Dynamics Between Amgen and Novartis.)
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