FDA approves Kedrab [rabies immune globulin (Human)]for passive, transient post-exposure prophylaxis of rabies infection.- Kedrion Biopharma + Kamada Ltd.

Kedrion Biopharma and Kamada Ltd. two leading human-derived protein therapeutics companies, announced that Kedrab [rabies immune globulin (Human)] has received FDA approval for passive, transient post-exposure prophylaxis of rabies infection, when given immediately after contact with a rabid or possibly rabid animal. Kedrab should be administered concurrently with a full course of rabies vaccine.

Rabies is a life-threatening condition that impacts approximately 40,000 people in the U.S. each year, representing an annual market opportunity of $100 million-plus. Kedrab will launch in the U.S. in early 2018. Prior to FDA approval of Kedrab, U.S. healthcare professionals had only two human rabies immune globulin (HRIG) therapy options from which to choose to prevent the onset of rabies in someone who may have been exposed to the deadly virus. Kedrab, a human plasma-derived immunoglobulin, is entering a rabies market that has experienced inconsistent supply in recent years.