Erenumab – 2018 Pipeline Review

Migraine is a debilitating disorder that affects millions of people in the United States. Migraine has the ability to affect individuals in a way that deprives them of their normal, daily activities, and often results in pain, physical impairment, lost productivity, and increased financial cost. Erenumab (Aimovig™, AMG-334) is a fully human monoclonal antibody being developed by Amgen Inc. in collaboration with Novartis Pharmaceuticals for the prevention of episodic and chronic migraine. Erenumab’s Biologics License Application was approved on July 20, 2017, and the drug candidate has been granted an upcoming PDUFA date of May 17, 2018. Erenumab has the potential to benefit patients who have experienced multiple treatment failures and have limited options available to them.

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Executive Summary of Evaluation:

   

Erenumab (Amgen Inc. / Novartis Pharmaceuticals)

Regulatory

 

Status

Pre-Registration

PDUFA

5/17/2018

  FDA Standard Review Designation

7/20/2017

  Patent Expiration

11/9/2031

     
Indications Migraine

Submitted for Approval (BLA)

     
Efficacy Migraine

Efficacy reported in Phase III Trials

References:

“Amgen Reports Aimovig™ (Erenumab) Met All Primary And Secondary Endpoints In Unique Phase 3b Study In Episodic Migraine Patients Who Have Failed Multiple Prior Preventive Treatments.” Amgen, 22 Jan. 2018, www.amgen.com/media/news-releases/2018/01/amgen-reports-aimovig-erenumab-met-all-primary-and-secondary-endpoints-in-unique-phase-3b-study-in-episodic-migraine-patients-who-have-failed-multiple-prior-preventive-treatments/.

Clinical Trial data obtained at https://clinicaltrials.gov/ct2/home Accessed: March 9, 2018.

Dodick DW, Ashina M, Brandes JL, Kudrow D, Lanteri-Minet M, et al. ARISE: A Phase 3 randomized trial of erenumab for episodic migraine. Cephalalgia. 2018 Jan 1:333102418759786.

Goadsby PJ, Reuter U, Hallström Y, Broessner G, Bonner JH, et al. A Controlled Trial of Erenumab for Episodic Migraine. N Engl J Med. 2017 Nov 30;377(22):2123-2132.

Pharma Intelligence Center https://pharma.globaldata.com Accessed: March 2, 2018.

 Additional 2018 Pipeline Reviews are available for the following drugs.

Tildrakizumab

Ibalizumab

Rituximab Biosimilars

 

Coauthored by: Kristen Ciampi, PharmD Candidate

Kristen is a sixth-year pharmacy student at the University of Rhode Island. Kristen is completing her studies through an advanced pharmacy practice rotation at RJ Health Systems prior to graduating with a PharmD degree in May of 2018.

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