Elanco Animal Health Inc. announced that the U.S. Department of Agriculture or USDA has issued a conditional license for its Canine Parvovirus Monoclonal Antibody.
The company expects to begin shipping Canine Parvovirus Monoclonal Antibody in the coming weeks, pending individual state approvals.
The targeted single-dose monoclonal antibody is the first and only approved targeted therapeutic solution proven to treat deadly dog disease. The conditional license approval was granted by the USDA to effectively and safely meet an emergency situation, limited market or special circumstance.
It is the first monoclonal antibody for Elanco, which recently received the U.S. Food and Drug Administration’s conditional approval for its Varenzin-CA1 to treat anemia in cats with chronic kidney disease.
The USDA conditional license is based on clinical trials that demonstrate the Canine Parvovirus Monoclonal Antibody single, intravenous dose delivers targeted efficacy in treating canine parvovirus.
In the treatment efficacy study, the Canine Parvovirus Monoclonal Antibody was proven effective in decreasing mortality associated with parvovirus infection.
The company noted that the treatment can be administered to dogs eight weeks of age or older with canine parvovirus. According to the firm, the treatment may provide a less intensive and more effective solution than supportive care alone by targeting the virus with single dose efficacy and a strong safety profile in healthy dogs.
Elanco will also continue to provide canine parvovirus education and resources to veterinarians, shelter owners and pet parents.
Canine parvovirus is one of the most contagious and deadly viruses a dog can contract with a 91 percent mortality rate if not treated with supportive care. Annually, an estimated 330,000 cases of canine parvovirus are reported for treatment in the U.S. Prior to Elanco’s Canine Parvovirus Monoclonal Antibody, the only treatment for the highly contagious canine parvovirus was supportive therapy, which can consist of 24/7 care and multi-day hospitalization.
Kristin Zersen, assistant professor of small animal emergency and critical care at Colorado State University Veterinary Teaching Hospital, said, “Parvovirus is an unpredictable disease that causes significant strain on pet owners and is labor intensive and stressful for shelters and veterinary clinic staff. It’s lifechanging and industry-defining to be able to offer a proven solution to canine parvovirus that limits the need for hospitalization, reducing the impact this disease has on hundreds of thousands of dogs each year.”
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