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.
For our complete review of Fremanezumab:
Executive Summary of Evaluation:
|Fremanezumab (Teva Pharmaceutical Industries Ltd)|
|FDA Fast Track (Cluster Headache Syndrome)
Priority Review Designation (Migraine)
|Indications||Migraine||Submitted for Approval (BLA)|
|Efficacy||Migraine||Efficacy reported in Phase III Trials|
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.
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.