Eptinezumab-JJMR

Recommends therapies targeting calcitonin gene-related peptide (CGRP) as a first-line option for migraine prevention MOUNT ROYAL, N.J., March 11, 2024 /PRNewswire/ -- The American Headache Society (AHS) published a consensus position statement today in Headache: The Journal of Head and Face Pain about the first-line role CGRP-targeting therapies should play in the prevention of migraine. Specifically, the AHS calls for CGRP-targeting therapies to be considered as a first-line approach for migraine prevention, along with previous first-line treatments, without a requirement for prior failure of other classes of migraine preventive treatment. The goal of preventive treatment is to reduce the frequency, intensity, duration, and disability associated with migraine attacks. AHS, the leading medical and scientific organization for healthcare professionals in migraine and other headache disorders, estimates that preventive therapy is indicated for approximately 40% of people with migraine, and many are unable to use existing first-line preventive migraine medicines due to limited effectiveness and tolerability. After a comprehensive review of clinical trial and real-world experience, the AHS found the evidence supporting the efficacy, tolerability, and safety of CGRP-targeting therapies—such as monoclonal antibodies (erenumab, fremanezumab, galcanezumab, and eptinezumab) and small-molecule CGRP receptor antagonists (rimegepant and atogepant)—for migraine prevention to be substantial in its volume, scope, and quality. "Moving CGRP-targeting therapies to the first line of treatment could have a transformational impact on the prevention of migraine attacks and their associated burdens," said Andrew Charles, MD, FAHS, position statement co-author and president of the American Headache Society. "Elevating CGRP-targeting therapies to the first line should reduce barriers for patients to receive these effective treatments and bring hope to countless people who experience this invisible, yet debilitating disease." The new position statement from the AHS, "Calcitonin gene-related peptide (CGRP)-targeting therapies are a first-line option for the prevention of migraine," provides guidance on how to integrate these treatments into clinical practice. ABOUT MIGRAINE Migraine is the third most common disease in the world. In the United States, an estimated 40 million Americans live with migraine. While migraine symptoms vary from person to person, common symptoms include severe headache; nausea and/or vomiting; increased sensitivity to light, sound, or smells; depressed mood or changes in mood; and yawning, fatigue, and difficulty sleeping. ABOUT THE AMERICAN HEADACHE SOCIETY The American Headache Society strives to improve the lives of people impacted by migraine and other headache disorders. The AHS is a professional society of health care providers dedicated to the study and treatment of headache and face pain. The Society's objective is to promote the exchange of information and ideas concerning the causes and treatments of headache and related painful disorders. Educating physicians, health professionals, and the public while encouraging scientific research are the primary functions of our Society. Learn more at AmericanHeadacheSociety.org. This consensus statement published by the American Headache Society (AHS) is an assessment of current scientific and clinical information that is provided as an educational service. The information should not be considered inclusive of all appropriate treatments. New evidence may develop between the time this statement is submitted and when it is published or read. This statement addresses only the question that is specifically identified. It does not mandate any particular course of medical care and is not intended to substitute for the independent professional judgment of the treating provider. CONTACT Tanya Kiniry [email protected] SOURCE American Headache Society

Charl Van Zyl took the helm at Lundbeck in October after several years at UCB. Lundbeck’s Charl van Zyl has about 100 days under his belt as the company’s new CEO. For the next 100 days and beyond, the chief exec is buckling down on his efforts to sustain the company's growth trajectory through upcoming patent cliffs. Van Zyl came to Lundbeck after a six-year stint at UCB, where he most recently served as that company’s head of neurology solutions. UCB credited the exec with integrating two major acquisitions after UCB bought Zogenix for $1.9 billion in 2022 and Ra Pharma for $2.5 billion in 2019. With that experience, van Zyl could be ready to strike deals for his new employer. Under a goal to bolster long-term growth prospects, Lundbeck’s approach to M&A is really “programmatic" and "systemic,” the CEO said in a recent interview. The strategy could include a series of “two or three” deals that build on the company’s existing strengths and enable it to balance its pipeline, the chief said. For now, Lundbeck has two strong growth drivers on hand with its antipsychotic Rexulti, which recently scored an FDA approval for Alzheimer’s disease agitation, and the migraine med Vyepti. Lundbeck's commercial efforts on those meds will command much of the company's attention as it works to grow in the medium term, the CEO said. Recently, Rexulti overtook the antidepressant Trintellix/Brintellix as Lundbeck’s top brand by sales, bringing in a haul of 3.3 billion DKK ($481 million) over the first nine months of 2023. The drug is still early in its Alzheimer’s agitation launch, but with a high unmet need in an area with “huge societal impact,” van Zyl is confident that for Lundbeck, “this is the right space to be [in].” The drug's rise comes at a good time. The company’s long-time largest product, Trintellix/Brintellix, is slated to lose patent protection at the end of 2026. Rexulti loses exclusivity in 2029, allowing Lundbeck a longer runway to grow the brand. Currently, Lundbeck is “investing significantly” to grow the med in its new use, particularly in the U.S. with direct-to-consumer ads, the CEO said. With a “strong cash flow” and a solid financial position, the time is right to invest and grow, van Zyl emphasized. Lundbeck's former CEO, Deborah Dunsire, stepped down in June after the 109-year-old company hit a record high for quarterly revenues. In a broader sense, the primary focus across the industry going into 2024 is trending toward setting the bar “very high” for innovation, especially in areas of unmet need. As for Lundbeck, the drugmaker is specifically active in chronic neuroscience as it looks to address lifelong conditions. Like many of its peers, upcoming patent cliffs are pushing Lundbeck toward building a pipeline that can deliver over many years. The company’s pipeline is still in relatively early stages, with many assets in phase 1 and phase 2. But out of those, van Zyl is “really excited” about its migraine prospects. In April, the drugmaker read out positive results of a proof-of-concept study testing a new migraine approach. If successful, the asset could complement Vyepti and help Lundbeck build out a portfolio of migraine prevention medicines.