FDA accepts for review a human anti-rabies immunoglobulin (IgG) therapy to treat rabies.- Kedrion Biopharma + Kamada Ltd

Kedrion Biopharma, and Kamada Ltd., two leading human-derived protein therapeutics companies, have announced that the 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.