Kamada and Kedrion Biopharma Announce Results of First and Only U.S. Post-Marketing Pediatric Trial of a Human Rabies Immune Globulin (HRIG); The Study Met Its Primary Objective
Kamada Ltd.
,
GlobeNewswire•August 19, 2020
- The Study of KEDRAB® (Rabies Immune Globulin [Human]) Conducted in Children was the First and Only Pediatric Study for any HRIG Available in U.S.
- The Study Met its Primary Objective, Which Was to Confirm the Safety of KEDRAB in the Pediatric Population.
- Study Results Have Been Submitted to the U.S. FDA for Review and Potential Update to the KEDRAB Prescribing Information.
- KEDRAB was Launched in the U.S. in 2018 and it Generated In-Market Sales of $31 Million in 2019, Representing Approximately 20 Percent Share of the U.S. HRIG Market.
(Ok Hold up Mr Hood... potential Update to prescribing info =$$$$$$)
KEDRAB is a human rabies immunoglobulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) treatment of rabies infection, when given promptly after contact with a rabid or possibly rabid animal.-- Kamada Ltd. (NASDAQ & TASE: KMDA) and Kedrion Biopharma, two leading biopharmaceutical companies specialized in plasma-derived protein therapeutics, today announced results from a U.S. post-marketing pediatric trial of KEDRAB® (Rabies Immune Globulin [Human]). The study represents the first and only trial of a currently available human
rabiesimmune globulin (HRIG) conducted in children in the U.S. to date. The results have been submitted to the U.S. Food and Drug Administration for review and inclusion as pediatric data in the KEDRAB full prescribing information. KEDRAB is a human rabies immunoglobulin (HRIG) indicated for passive, transient post-exposure prophylaxis (PEP) treatment of rabies infection, when given promptly after contact with a rabid or possibly rabid animal.
The KEDRAB U.S. Pediatric Trial was conducted at two sites, one in Arkansas and another in
Rhode Island. The study included 30 pediatric patients (ages 0-17 years old), each of whom received KEDRAB as part of PEP treatment following exposure or suspected exposure to an animal suspected or confirmed to be rabid, and safety follow-up was conducted for up to 84 days. The primary objective of the study was to confirm the safety of KEDRAB in the pediatric population. Secondary objectives included the evaluation of antibody levels and the efficacy of KEDRAB in the prevention of rabies disease when administered with a rabies vaccine according to the PEP recommended guidelines.
No serious adverse events were observed during the study. No incidence of rabies disease or deaths were recorded throughout the 84-day study period.
“These key study results represent the first clinical trial data in the U.S. pediatric population for any HRIG currently available in the US,” said Michal Stein, M.D., Vice President, Medical Director (Immunology) at Kamada. “According to the World Health Organization,
40 percent of people bitten by suspected rabid animals are children under 15 years of age. Despite the large proportion of pediatric cases, limited safety and efficacy data from clinical trials currently exist for this population. Meeting the primary study objective of KEDRAB in children further strengthens our ongoing confidence in the product.
We continue to believe that sales of KEDRAB has the potential to continue growing in the U.S., capturing a significant share of the estimated annual $150 million U.S. HRIG market.”
KEDRAB was launched in the U.S. in April 2018 and generated in-market sales of
$31 million in 2019, representing approximately 20 percent of the U.S. HRIG market.
(Ok... Mr Hood--so KMDA should now be first in class and grab more share of the rabies market! If 20% becomes 40% then $31 mil becomes $62 mil... not bad not bad at all that will help pay for the upcoming COVID Plasma trials... Not everything can be a Billion $ opportunity in biotech sometimes we just have to help people that have been bit! Listen one year we had two bats in the house.. If I had been bit what would I have done? we had a rabid racoon one year came right at my landscaper/helper who fended him off with a Chainsaw! and he kept coming.. I watched the whole thing half way up a tree... Stuff happens in the woods Bobcats... yup.. and in Australia this is an issue when dogs jump of boats ans they often do.. Ah The French! Always with the dog...)
Lets Not Punish some Good people in Israel for coming out with news that is not Covid related... patience...
