"This conditional approval provides a much-needed option to treat dogs with lymphoma," said Steven M. Solomon, D.V.M., M.P.H., director of the FDA's Center for Veterinary Medicine.
LAVERDIA-CA1 is a novel antineoplastic therapeutic that represents a milestone innovation in canine lymphoma care. It is the first small-molecule selective inhibitor of nuclear export (SINE) drug specifically designed for dogs. As a lymphoma treatment in tablet form, veterinarians can prescribe, and dogs can now receive treatment in the comfort of their own homes.
Cheryl London, DVM, PhD, DACVIM, Professor, Tufts University. "This presents a paradigm shift in the treatment of lymphoma and has the potential to become routine, 'standard of care' treatment for dogs."
LAVERDIA-CA1 is designed to treat all forms of canine lymphoma. Peer-reviewed published clinical studies evaluating LAVERDIA-CA1 (verdinexor) showed reasonable expectation of efficacy in both B-cell and T-cell lymphoma—in both naïve and relapsed cases. LAVERDIA-CA1 has a different mechanism than other therapies and does not cause bone marrow suppression typical of traditional untargeted cytotoxic therapies.
Anivive has been focused on developing LAVERDIA-CA1 as a new treatment for the more than 700,000 dogs diagnosed with lymphoma every year. Nearly 80% of dog owners decline treatment, for a variety of reasons: limited access to a veterinary oncologist; quality of life concerns related to the severe side effects that can accompany traditional chemotherapy; difficulties following through with the chemotherapy regime; and high cost of treatment. This leaves behind more than 2,000 bereaved families every day.
Because LAVERDIA-CA is in tablet form, dogs can be treated safely at home and is affordably priced, opening up access to care to more dogs suffering from lymphoma.
"We are excited that our new treatment is going to expand the number of dogs who receive cancer care," says Anivive's Chief Medical Officer, David Bruyette DVM, DACVIM.
LAVERDIA-CA1 (verdinexor), is conditionally approved by the FDA pending a full demonstration of effectiveness under application number 141-526. Conditional approval allows veterinarians to access LAVERDIA-CA1 as Anivive continues clinical trials to support full approval.
"I believe Laverdia is the first in long list of first-in-class therapeutics our team will develop for unmet conditions in pets," says Dylan Balsz, CEO of Anivive. "We're a different kind of pharmaceutical company, dedicated to dramatically accelerating time to market of new drugs at significantly reduced cost to veterinarians and pet owners."
Applying data science and AI to veterinarians' unmet needs
Anivive is dedicated to creating intelligent treatments for pets so that veterinarians have more tools to treat the diseases they encounter in their practices. Anivive identified verdinexor as a promising therapeutic candidate through AniviveSELECT, Anivive's proprietary AI-powered software. AniviveSELECT accelerates the drug discovery process by analyzing and learning from a massive collection of drug data compiled from more than 300 sources.
About LAVERDIA-CA1 (verdinexor tablets)
LAVERDIA-CA1 is a new oral treatment option for canine lymphoma. It is the first small-molecule selective inhibitor of nuclear export (SINE) drug specifically designed for veterinarian use. It employs a novel targeted mechanism of action where it targets and binds to Exportin-1 (XPO1) – a "transport" protein that proliferates in certain types of cancer. Excessive amounts of XPO1 export important tumor suppressing proteins (TSPs) – necessary for fighting cancer – from the nuclei of cells, rendering them vulnerable to uncontrolled growth. With its targeted blocking of XPO1, LAVERDIA-CA1 allows for TSPs to be trapped inside the cell nucleus, triggering programmed cell death of lymphoma cells while sparing healthy cells. The most commonly reported side effects include anorexia, vomiting, diarrhea, weight loss, and lethargy.
Anivive is reinventing the drug development process in pet pharma. Our unique approach accelerates the delivery of new, affordable treatments for pets. With proprietary software, predictive analytics, and novel therapeutics, we're pushing the limits of what's possible in pet care. By collaborating with researchers, data scientists, pet owners and veterinarians, we are developing breakthrough treatments for pets' biggest unmet medical needs – and improving the lives of pets and their families. For additional information, visit www.anivive.com.