Calcitonin gene-related peptide receptor antagonists

Teva Announces Ministry of Health, Labour and Welfare Approves AJOVY® (fremanezumab) Injection in Japan for the Preventive Treatment of Migraine in Adults

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Mercredi, juin 23, 2021

Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Ministry of Health, Labour and Welfare (MHLW) has approved the use of AJOVY (fremanezumab) injection for the preventive treatment of migraine in adults in Japan.

Key Points: 
  • Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) today announced the Ministry of Health, Labour and Welfare (MHLW) has approved the use of AJOVY (fremanezumab) injection for the preventive treatment of migraine in adults in Japan.
  • Driven by our global mission to improve patients lives, we are pleased to offer this new treatment option to people living with migraine in Japan.
  • In 2020, the two companies announced outcomes from two pivotal studies of AJOVY in people living with episodic and chronic migraine in Japan.
  • AJOVY is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.

Teva to Present Latest Data on AJOVY® (fremanezumab-vfrm) Injection at the 2021 American Headache Society (AHS) Annual Meeting, Showcasing Teva’s Longstanding Heritage in the Management of Migraine

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Jeudi, juin 3, 2021

The data being presented at this years AHS meeting underscore the impact AJOVY can have on the healthcare community as seen in clinical analyses and real-world experiences.

Key Points: 
  • The data being presented at this years AHS meeting underscore the impact AJOVY can have on the healthcare community as seen in clinical analyses and real-world experiences.
  • AJOVY can be administered in office by a healthcare professional or at home by a patient or caregiver.
  • AJOVY is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.
  • Teva Pharmaceutical Industries Ltd. (NYSE and TASE: TEVA) has been developing and producing medicines to improve peoples lives for more than a century.

FDA Approves Biohaven's NURTEC® ODT (rimegepant) for Prevention: Now the First and Only Migraine Medication for both Acute and Preventive Treatment

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Jeudi, mai 27, 2021

This new approval makes NURTEC ODT the first oral CGRP antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both the acute and preventive treatment.

Key Points: 
  • This new approval makes NURTEC ODT the first oral CGRP antagonist approved for the preventive treatment of migraine, and the only migraine medication approved as a dual therapy for both the acute and preventive treatment.
  • NURTEC ODT is approved for acute treatment in all eligible adult patients with migraine, regardless of the number of monthly migraine days.
  • NURTEC ODT, with its novel quick-dissolve tablet formulation, works by blocking the CGRP receptor, treating a root cause of migraine.
  • It is for the acute treatment of migraine attacks with or without aura and the preventive treatment of episodic migraine.

New Study Published in Cephalalgia Identifies Mechanistic Differences Among CGRP Migraine Treatments

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Vendredi, février 26, 2021

This study demonstrated marked differences in the mechanism of blocking the calcitonin gene-related peptide (CGRP) ligand versus the CGRP receptor.

Key Points: 
  • This study demonstrated marked differences in the mechanism of blocking the calcitonin gene-related peptide (CGRP) ligand versus the CGRP receptor.
  • For instance, fremanezumab in particular, as a monoclonal antibody against the CGRP ligand, is targeted and specific in its mechanism.
  • AJOVY (fremanezumab-vfrm) injection is a fully humanized IgG2A monoclonal antibody that specifically and solely targets CGRP, a key neuropeptide involved in the pathophysiology of migraine.
  • Clinical implications of these findings are unknown, but the in vitro studies provide insights into potential mechanistic differences.

Sosei Heptares and Biohaven Enter Global Collaboration and License Agreement to Advance Novel Small-Molecule CGRP Antagonist Portfolio

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Mardi, décembre 1, 2020

Under the agreement, Biohaven will receive exclusive global rights to develop, manufacture and commercialize a portfolio of novel, small-molecule CGRP receptor antagonists discovered by Sosei Heptares for the treatment of CGRP-mediated disorders.

Key Points: 
  • Under the agreement, Biohaven will receive exclusive global rights to develop, manufacture and commercialize a portfolio of novel, small-molecule CGRP receptor antagonists discovered by Sosei Heptares for the treatment of CGRP-mediated disorders.
  • In addition, Sosei Heptares will be eligible to receive tiered royalties on net sales of products resulting from the collaboration.
  • Vlad Coric, M.D., Chief Executive Officer of Biohaven, said: "We are excited to enter into this agreement with Sosei Heptares, a world leader in GPCR drug discovery.
  • Shinichi Tamura, Chairman, President and CEO of Sosei Heptares, commented:"We are delighted to enter this collaboration and license agreement with Biohaven for our portfolio of novel CGRP receptor antagonists.

AbbVie to Present New Data From 15 Abstracts at the 2020 Virtual Migraine Trust International Symposium

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Vendredi, octobre 2, 2020

In total, 15 abstracts will be presented evaluating the safety, efficacy, and impact on patients and the healthcare system of AbbVie's migraine treatment portfolio, including BOTOX (onabotulinumtoxinA) and UBRELVY(ubrogepant).

Key Points: 
  • In total, 15 abstracts will be presented evaluating the safety, efficacy, and impact on patients and the healthcare system of AbbVie's migraine treatment portfolio, including BOTOX (onabotulinumtoxinA) and UBRELVY(ubrogepant).
  • Findings from nine abstracts evaluating treatment with BOTOX in clinical and real-world settings will be presented as posters, also available on demand October 3-9.
  • Atogepant is an investigational orally administered, CGRP receptor antagonist (gepant) specifically developed for the preventive treatment of migraine.
  • Studies have shown that CGRP levels are elevated during migraine attacks and selective CGRP receptor antagonists confer clinical benefit in migraine.

Recent Label Revisions Related to Constipation and Hypertension Generate Minimal Drag on the Decision to Prescribe Amgen/Novartis' Aimovig as a Preventive Treatment for Migraine

Retrieved on: 
Mardi, août 18, 2020

First-to-market Amgen/Novartis' Aimovig remains the most frequently prescribed CGRP mAb, with recent label revisions related to constipation and hypertension having minimal impact on real world prescribing patterns.

Key Points: 
  • First-to-market Amgen/Novartis' Aimovig remains the most frequently prescribed CGRP mAb, with recent label revisions related to constipation and hypertension having minimal impact on real world prescribing patterns.
  • When Aimovig was selected over Emgality, less managed care hassle and expectations of greater efficacy were the most common reasons.
  • To remain competitive, Eli Lilly should continue to highlight Emgality's unique expanded label with indications for both the preventive treatment of migraine and the treatment of episodic cluster headache.
  • The FDA has twice revised the Aimovig label within the past year, adding Warning and Precaution sections related to the risk of severe constipation and worsening hypertension.

AbbVie to Showcase 27 Studies at the Virtual 2020 Annual Scientific Meeting of the American Headache Society

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Lundi, juin 15, 2020

NORTH CHICAGO, Ill., June 15, 2020 /PRNewswire/ --AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that it has 27 studies accepted to the virtual 2020 Annual Scientific Meeting of the American Headache Society (AHS).

Key Points: 
  • NORTH CHICAGO, Ill., June 15, 2020 /PRNewswire/ --AbbVie (NYSE: ABBV), a research-based global biopharmaceutical company, today announced that it has 27 studies accepted to the virtual 2020 Annual Scientific Meeting of the American Headache Society (AHS).
  • We are thankful the American Headache Society continues to recognize these significant scientific advancements."
  • UBRELVY, approved in December of 2019, is a first-to-market, orally-administered CGRP receptor antagonist (or gepant) for the acute treatment of migraine.
  • Studies have shown that CGRP levels are elevated during migraine attacks and selective CGRP receptor antagonists confer clinical benefit in migraine.

Orsini Pharmaceutical Services Selected To Provide VYEPTI™ (eptinezumab-jjmr) - The First And Only Intravenous Preventive Treatment For Migraine

Retrieved on: 
Mercredi, avril 22, 2020

The approved product is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.

Key Points: 
  • The approved product is a calcitonin gene-related peptide antagonist indicated for the preventive treatment of migraine in adults.
  • Migraine is a seriously debilitating condition that afflicts an estimated 39 million people in the U.S., disrupting their lives in significant ways.
  • The entire team at Orsini looks forward to supporting the needs of migraine sufferers and their caregivers."
  • The company's comprehensive solutions include nursing coverage nationwide for required in-home infusion services, data analytics, and medication adherence, among others.

Biohaven Enters Into Partnership With Medison Pharma To Distribute NURTEC™ ODT In Israel

Retrieved on: 
Jeudi, avril 16, 2020

NEW HAVEN, Conn., April 16, 2020 /PRNewswire/ --Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") and Medison Pharma, Israel's leading partner for innovative pharmaceuticals, announced today an agreement to distribute NURTEC ODT (rimegepant) in Israel.

Key Points: 
  • NEW HAVEN, Conn., April 16, 2020 /PRNewswire/ --Biohaven Pharmaceutical Holding Company Ltd. (NYSE: BHVN) ("Biohaven") and Medison Pharma, Israel's leading partner for innovative pharmaceuticals, announced today an agreement to distribute NURTEC ODT (rimegepant) in Israel.
  • Medison has strong distribution, medical and access capabilities with a proven track record of delivering innovative products successfully to patients in Israel.
  • We are excited to partner with Medison to bring what we believe is the best-in-class oral small molecule CGRP-antagonist NURTECODT to migraine patients in Israel."
  • The agreement between Biohaven and Medison includes NURTEC ODT, approved in the USA on February 27, 2020 for the acute treatment of migraine.