Fremanezumab – 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. Fremanezumab (TEV-48125), developed by Teva Pharmaceutical Industries Ltd., is a fully humanized monoclonal antibody being studied for the preventative treatment of episodic and chronic migraine. Fremanezumab was granted Priority Review from the FDA for its migraine indication on December 18, 2017, with an upcoming PDUFA date of September 16, 2018.

 

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Executive Summary of Evaluation:

    Fremanezumab (Teva Pharmaceutical Industries Ltd)
Regulatory

 

Status Pre-Registration
PDUFA 9/16/2018
  FDA Fast Track (Cluster Headache Syndrome)

Priority Review Designation (Migraine)

12/18/2017
  Patent Expiration 8/20/2027
     
Indications Migraine Submitted for Approval (BLA)
     
Efficacy Migraine Efficacy reported in Phase III Trials

References:

Clinical Trial data obtained at https://clinicaltrials.gov/ct2/home Accessed: March 19, 2018.

Pharma Intelligence Center https://pharma.globaldata.com Accessed: March 19, 2018.

Silberstein SD, Dodick DW, Bigal ME, Yeung PP, Goadsby PJ, et al. Fremanezumab for the Preventive Treatment of Chronic Migraine. N Engl J Med. 2017 Nov 30;377(22):2113-2122.

Teva Latest News http://www.tevapharm.com/news/teva_confirms_september_pdufa_date_for_fremanezumab_05_18.aspx Accessed: May 23, 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.

For our complete review of Fremanezumab:

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