FDA Approves KEDRAB for Post-Exposure Prophylaxis Against Rabies Infection

The US Food and Drug Administration (FDA) recently approved a post-exposure prophylaxis against rabies infection.

A human plasma-derived immunoglobulin (HRIG), the rabies immune globulin (KEDRAB) will be launched by creator Kamada Ltd. and Kedrion Biopharma in the United States in early 2018.

KEDRAB's efficacy as a rabies treatment was measured in a single-center, randomized, comparator HRIG-controlled clinical study consisting of 118 adult patients without any significant acute or chronic illnesses. Patients were split evenly (59 each) between treatment and control groups, receiving doses of KEDRAB or HRIG at 20 lU/kg intramuscularly at the trial's beginning, then rabies vaccine on Days 0,3,7,14, and 28.

Efficacy analyses were performed on the treated population, which comprised the 116 study subjects who received KEDRAB or comparator HRIG and at least 3 of the 5 doses of rabies vaccine before Day 14. Adverse reactions in KEDRAB patients included injection site pain and headaches, among others.

Rabies currently affects about 40,000 individuals in the United States annually. KEDRAB is advised for use promptly after contact with a rabid or possibly rabid animal, concurrently with a full course of rabies vaccine.

KEDRAB is not Kamada's first venture into treatments suitable for potentially deadly, but preventable rabies infection. An HRIG product called KamRAB has been marketed outside of the United States for more than a decade. However, the most recently approved HRIG is a notable milestone for the company's venture into the US market.

"The approval of KEDRAB represents the first product that Kedrion Biopharma has had a role in developing throughout its clinical development and through to commercialization in the US," Paolo Marcucci, president and chief executive officer of Kedrion, said in a recent press release. "As Kedrion Biopharma is one of the world’s leading suppliers of high-titer rabies plasma, we are well-positioned to maximize the potential of this product, and we look forward to working with Kamada to launch KEDRAB in the United States.”

Kamada chief executive officer Amir London added that the treatment represents "an annual market opportunity of over $100 million in the United States. Moreover, this has the potential to be a highly profitable product for our companies. Meaningful sales from KEDRAB are expected to ramp up in 2018, during its first full year of launch."