Kedrion Biopharma And Kamada Announce FDA Acceptance Of BLA Submission For Human Rabies Immunoglobulin As A Post-Exposure Treatment

  • PDUFA goal date of August 29, 2017
  • If approved, product would represent new treatment option in $100M-plus market where supply of post-exposure rabies treatment has been inconsistent over time

FORT LEE, N.J. and NESS ZIONA, Israel, Nov. 07, 2016 (GLOBE NEWSWIRE) -- Kedrion Biopharma, and Kamada Ltd. (NASDAQ:KMDA) (TASE:KMDA), two leading human-derived protein therapeutics companies, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a Biologics License Application ( BLA) for a human anti-rabies immunoglobulin (IgG) therapy. Rabies is a life-threatening condition that impacts approximately 40,000 people in the U.S. each year. At present, U.S. healthcare professionals have only two rabies IgG therapy options from which to select in preventing the onset of rabies in someone who may have been exposed to the deadly virus.  The post-exposure prophylaxis treatment being developed by Kedrion Biopharma and Kamada is a human plasma-derived immunoglobulin (IgG) and has the potential to provide stability and secure availability in a market that has experienced inconsistent supply and supply shortages in recent years.

The FDA has assigned a Prescription Drug User Fee Act (PDUFA) goal date of August 29, 2017, for completion of the review of the BLA.  Kedrion Biopharma and Kamada intend to launch the product soon after a favorable decision is received.

Kamada has been selling the anti-rabies IgG product since 2003 in numerous territories outside of the U.S. under the brand name KamRAB™. Kamada has sold more than one million vials of the product to date, demonstrating significant clinical experience with the product.

The BLA currently under review by FDA is based on results announced in December 2015 from a prospective, randomized, double-blind, non-inferiority Phase 2/3 study of 118 healthy subjects.

"The FDA's review of this application is an encouraging step toward bringing to market a needed new treatment option for post-exposure prophylaxis of rabies," said Garrett Bergman, M.D., Senior Director, Medical Affairs at Kedrion Biopharma. "Rabies is a completely preventable condition, and emergency room healthcare professionals and pharmacists, in particular, will welcome the arrival of an additional choice in providing urgent medical care to those who may have been exposed to this deadly virus."

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