Aimovig (erenumab-aooe) / Amgen, Novartis 
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 12 Diseases   17 Trials   17 Trials   2487 News 


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  • ||||||||||  Herceptin (trastuzumab) / Roche, Ultomiris IV (ravulizumab IV) / Alexion Pharma
    Journal:  Antibodies to watch in 2019. (Pubmed Central) -  Aug 1, 2019   
    In addition, our data show that 3 product candidates (leronlimab, brolucizumab, polatuzumab vedotin) may enter regulatory review by the end of 2018, and at least 12 (eptinezumab, teprotumumab, crizanlizumab, satralizumab, tanezumab, isatuximab, spartalizumab, MOR208, oportuzumab monatox, TSR-042, enfortumab vedotin, ublituximab) may enter regulatory review in 2019...Of these, 7 (tremelimumab, spartalizumab, BCD-100, omburtamab, mirvetuximab soravtansine, trastuzumab duocarmazine, and depatuxizumab mafodotin) are being evaluated in clinical studies with primary completion dates in late 2018 and in 2019, and are thus 'antibodies to watch'. We look forward to documenting progress made with these and other 'antibodies to watch' in the next installment of this article series.
  • ||||||||||  Botox (onabotulinumtoxin A) / GSK, Allergan
    Journal:  Preventive Therapy of Migraine. (Pubmed Central) -  Jul 26, 2019   
    Individual treatment recommendations are determined based upon evidence for efficacy, side effect and adverse event profiles, medication interactions, patient comorbidity, costs, and patient preferences. Patients must be counseled on reasonable expectations for their preventive therapy and the importance of adhering to the recommended treatment plan for a period of time that is sufficient to determine outcomes.
  • ||||||||||  Journal:  Primary headache disorders: Five new things. (Pubmed Central) -  Jul 26, 2019   
    For patients seeking a nondrug therapy, neuromodulation approaches, single-pulse transcranial magnetic stimulation, noninvasive vagus nerve stimulation (nVNS), and external trigeminal nerve stimulation, represent licensed, well-tolerated approaches to migraine treatment...Headache medicine has made remarkable strides, particularly in understanding migraine and cluster headache in the past 5 years. For the most common reason to visit a neurologist, therapeutic advances offer patients reduced disability and neurologists a rewarding, key role in improving the lives of those with migraine and cluster headache.
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Enrollment open:  OASIS (EM): Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine (clinicaltrials.gov) -  Jul 22, 2019   
    P3,  N=456, Recruiting, 
    For the most common reason to visit a neurologist, therapeutic advances offer patients reduced disability and neurologists a rewarding, key role in improving the lives of those with migraine and cluster headache. Not yet recruiting --> Recruiting
  • ||||||||||  Aimovig (erenumab) / Amgen, Novartis
    Review, Journal:  CGRP and headache: a brief review. (Pubmed Central) -  Jul 12, 2019   
    Pent-up demand for designer, well-tolerated, and effective migraine preventive medication in the USA has resulted in more than 100,000 individual patients prescribed erenumab from May to December of 2018, and the numbers continue to increase. The preventive treatment of migraine in the USA has shifted dramatically, and is likely to do so in the rest of the world as well.
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Trial completion date, Trial primary completion date:  AMG 334 20160172 Pediatric Migraine PK Study. (clinicaltrials.gov) -  Jul 9, 2019   
    P1,  N=60, Recruiting, 
    The preventive treatment of migraine in the USA has shifted dramatically, and is likely to do so in the rest of the world as well. Trial completion date: Sep 2021 --> Jun 2021 | Trial primary completion date: Dec 2020 --> Jun 2020
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Trial completion:  A Safety and Efficacy Study to Evaluate AMG 334 in Migraine Prevention (clinicaltrials.gov) -  Jul 1, 2019   
    P2,  N=475, Completed, 
    Erenumab did not adversely affect exercise time in a high cardiovascular risk population of patients, supporting that inhibition of the canonical CGRP receptor does not worsen myocardial ischemia. Active, not recruiting --> Completed
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Enrollment open:  Study of Sustained Benefit of AMG334 in Adult Episodic Migraine Patients (clinicaltrials.gov) -  May 21, 2019   
    P4,  N=600, Recruiting, 
    Erenumab was generally well tolerated with an acceptable safety profile, supporting further clinical development of erenumab for migraine prevention. Not yet recruiting --> Recruiting
  • ||||||||||  Aimovig (erenumab) / Amgen, Novartis
    Clinical, Journal:  Erenumab: First Global Approval. (Pubmed Central) -  May 17, 2019   
    Based on these positive results erenumab was recently approved in the US for the preventive treatment of migraine in adults and has received a positive opinion in the EU for the prophylaxis of migraines in adults who have at least 4 migraine days per month. This article summarizes the milestones in the development of erenumab leading to this first approval.
  • ||||||||||  Emgality (galcanezumab) / Eli Lilly, Aimovig (erenumab) / Amgen, Novartis
    Clinical, Review, Journal:  Anti-CGRP and anti-CGRP receptor monoclonal antibodies as antimigraine agents. Potential differences in safety profile postulated on a pathophysiological basis. (Pubmed Central) -  Apr 25, 2019   
    ...These concerns were correctly addressed by the anti-CGRP receptor mABs erenumab with a 5-year open-label clinical trial; however, this study is currently ongoing and results are not yet available, leaving some uncertainty on the profile of erenumab long-term safety...Assuming that plasma CGRP is an indirect marker of peptide levels at the vascular receptor sites, such residual CGRP would maintain a physiological level of receptor stimulation, in spite of a well-established anti-migraine activity of the mABs. This might represent a potential advantage in the safety profile of anti-CGRP mABs, but it needs to be confirmed and expanded with data on free plasma CGRP.
  • ||||||||||  Aimovig (erenumab-aooe) / Amgen, Novartis
    Enrollment open:  A Controlled Trial of Erenumab in Migraine Prevention (clinicaltrials.gov) -  Apr 23, 2019   
    P3,  N=256, Recruiting, 
    This might represent a potential advantage in the safety profile of anti-CGRP mABs, but it needs to be confirmed and expanded with data on free plasma CGRP. Not yet recruiting --> Recruiting