Ajovy™ (Fremanezumab-vfrm) – 2018 FDA Approval

FDA Approval: 9/14/18

Migraine is a debilitating disorder that affects millions of people in the United States. Migraine can 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-vfrm, developed by Teva Pharmaceutical Industries Ltd., is a fully humanized monoclonal antibody studied for the preventative treatment of episodic and chronic migraine. Fremanezumab-vfrm was granted Priority Review from the FDA for its migraine indication on December 18, 2017, with an original PDUFA date of June 16, 2018.  In May of 2018 the PDUFA date was extended three months with FDA approval granted on September 14, 2018.

For our complete review of Fremanezumab-vfrm (Ajovy TM):

Executive Summary of Evaluation:

    Fremanezumab-vfrm (Teva Pharmaceutical Industries Ltd)
Regulatory

 

Status Marketed
PDUFA

(Original)

(Updated)

 

6/16/2018

9/16/18

  FDA Fast Track (Cluster Headache Syndrome)

Priority Review Designation (Migraine)

12/18/2017
  FDA Approval (Migraine Prevention) 9/14/18
  Patent Expiration 8/20/2027
     
Indications Migraine Approved (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.

U.S. Food & Drug Administration Drugs@FDA: FDA Approved Drug Products Product Labeling https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/761089s000lbl.pdf  Accessed: September 24, 2018.

Additional 2018 Pipeline Reviews are available in our pipeline library.

Please see the August 2018 FDA Actions Newsletter for additional information on recent FDA approvals

Coauthored by: Kristen Ciampi, PharmD

Kristen recently graduated with a PharmD degree from the University of Rhode Island in May of 2018, and is a Pharmacy Analytics Intern at RJ Health Systems. 

Leave a Reply