Kamada Ltd. (KMDA -8.1%), along with Kedrion Biopharma, announces positive data from a U.S. post-marketing study assessing the safety of rabies treatment Kedrab (rabies immune globulin [human]) in children, the first such study conducted in a pediatric population.
The 30-subject study was conducted at two sites, one in Arkansas and the other in Rhode Island. Each participant received Kedrab for post-exposure prophylaxis (PEP) after exposure or suspected exposure to an infected animal.
Safety follow-up was up to 84 days. No serious adverse events were observed and no cases of rabies or deaths were reported.
The data have been submitted to the FDA for review and possible labeling update.
Kedrab was launched in the U.S. in April 2018. Sales last year were $31M representing ~20% market share.
Shares are down on the FDA’s hold on emergency use authorization of convalescent plasma for COVID-19.
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