Rare Disease Therapeutics, Inc. Announces New Expanded FDA Approved Indication for Antivenom ANAVIP® for Treatment of North American Pit Viper Envenomation

Rare Disease Therapeutics, Inc. (RDT) announced that the United States (US) Food & Drug Administration (FDA) approved a new expanded indication for ANAVIP® (crotalidae immune F(ab’)2 (equine)), an equine-derived antivenin, for the management of adult and pediatric patients with North American Pit Viper envenomation. This new expanded indication now includes Rattlesnake, Copperhead, and Cottonmouth/Water Moccasin envenomations. ANAVIP was previously indicated for the management of adult and pediatric patients with North American rattlesnake envenomation. RDT exclusively markets ANAVIP in the US in partnership with manufacturer Laboratorios Silanes, S.A. de C.V., a worldwide leader in antivenom technologies.

ANAVIP was specifically engineered with a long half-life to minimize the likelihood of re-emergent venom effects (such as a drop in platelets, prolonged bleeding times, and other abnormal blood clotting tests) that commonly require additional doses of a shorter-acting antivenom. ANAVIP controlled local, systemic, and hematologic symptoms for all Pit Viper envenomation patients studied1,2. No patients in clinical trials required retreatment with ANAVIP for late venom effects1,2.

“This new expanded indication demonstrates not only the remarkable scientific value of ANAVIP, but also the significant unmet need for treatment options that has existed for North American Pit Viper envenomated patients in the US,” said Milton Ellis, Founder and Chief Executive Officer of RDT. “After decades of focus on this overlooked patient need, we are pleased to provide the thousands of North American Pit Viper envenomated patients in the US with a new treatment option, furthering RDT’s mission of bringing necessary treatments for rare conditions to market.”

7,000–8,000 people are bitten by venomous snakes in the US annually3. North American Pit Vipers include Rattlesnakes, Copperheads, and Water Moccasins (also known as Cottonmouths). Because people seek – and receive – rapid medical intervention, the number of deaths from snakebites is low (about 5 per year)3. However, coagulopathies (blood clotting disorders) can be major complications of a venomous Pit Viper snakebite, and one of the goals of treatment is to limit the potential incidence of late coagulopathies2.

“After serving as RDT’s Medical Science Liaison for roughly a decade and leading as President during the launch of ANAVIP in 2019, I’m very pleased to see the science behind ANAVIP now being applied successfully to the treatment of a broader set of snakebites,” said Jude McNally, President of RDT. “ANAVIP, with its ease of dosing and reduction of late coagulopathies, is now a vital treatment option for not only Rattlesnake envenomated patients, but for all patients with any North American Pit Viper envenomation – a group that prior to this approval, has had very limited treatment options.”