FDA Accepts BLA for Rabies Post-Exposure Treatment

Kedrion Biopharma and Kamada announce FDA acceptance of BLA submission for human rabies immunoglobulin as a post-exposure treatment.

Kedrion Biopharma and Kamada Ltd., two human-derived protein therapeutics companies, 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.”

“The FDA’s acceptance of our BLA for review is a significant milestone for Kamada,” said Amir London, Kamada’s chief executive officer. “This is an indication with limited treatment options in the U.S. and we are confident that this therapy has the potential to gain meaningful market share in the U.S. over time. Kedrion has significant expertise in commercializing plasma-derived therapies and we look forward to continuing the successful collaboration between our companies.”

“We are excited about the commercial potential for our rabies IgG therapy in the U.S., where approximately 40,000 post-exposure prophylaxis treatments are administrated each year, representing an annual market opportunity of over $100 million,” said Larry Guiheen, chief commercial officer at Kedrion Biopharma. “Currently, in the U.S., a single company is responsible for supplying most of the rabies IgG therapy to the market. Therefore, we anticipate that healthcare professionals will want to diversify their source of product supply, particularly if a competing product, such as the one Kedrion Biopharma and Kamada have under development, is approved for use. Further, Kedrion Biopharma is one of the world’s leading suppliers of high-titer rabies plasma. We understand this space well and are looking forward to a favorable regulatory outcome and a successful product launch of our rabies IgG therapy.”

Under the clinical development and marketing agreement between Kedrion Biopharma and Kamada, subject to the product receiving FDA marketing approval, Kamada will hold the license for it and Kedrion Biopharma will have exclusive rights to commercialize it in the U.S.

Kedrion S.p.A. is an international company that collects and fractionates blood plasma to produce and distribute plasma-derived therapeutic products for use in treating and preventing serious diseases, disorders and conditions such as hemophilia, primary immune system deficiencies and Rh sensitization which can lead to hemolytic disease of the fetus and newborn. Kedrion Biopharma Inc., the US subsidiary of Kedrion, is headquartered in Fort Lee, NJ. www.kedrion.com and www.kedrion.us.

Kamada Ltd. is focused on plasma-derived protein therapeutics for orphan indications, and has a commercial product portfolio and a late-stage product pipeline. The company’s flagship product is Glassia, a liquid, ready-to-use, intravenous plasma-derived AAT product approved by the U.S. FDA. Kamada markets Glassia in the U.S. through a strategic partnership with Baxalta (formerly Baxter International Inc.’s BioScience business and now part of Shire plc and in other counties through local distributors. www.kamada.com.

(Source: Business Wire)