The US Food and Drug Administration (FDA) announced last week that it had approved Elanco's gas reduction medicated feed additive lubabegron or Experior. The Type A medicated article is a “beta-adrenergic agonist/antagonist” drug.
Elanco Animal Health Incorporated’s product was approved for use with beef cattle for the last 14 to 91 days on feed, the FDA reported.
The product is the first animal drug approved for use to reduce the emission of ammonia gas from an animal or its waste, said Steven Solomon, director of the FDA’s Center for Veterinary Medicine.
“We’re committed to supporting the development of novel animal drug products that are safe and effective, and we’re encouraged to see innovations that provide additional benefits to animals, people and the environment,” he said about the approval. “These ammonia gasses can come from many sources and can affect the health of people, animals and the environment. Novel animal drug products such as these also support One Health approaches to public health.”
The product is an effort to address customer environmental concerns, said Elanco.
“This innovation is an important new tool that should enable beef producers to care for their cattle and the environment,” said Aaron Schacht, executive VP of innovation, regulatory and business development at Elanco Animal Health.
FDA review
There is a concern about ammonia gas emissions because high concentrations can irritate the eyes, nose and throat for animals and humans, the FDA said. Ammonia gas also can contribute to eutrophication, a process that occurs when bodies of water gain excess nutrients, including nitrogen and phosphorus, and which can lead to algae blooms.
Multiple studies demonstrated that the feed additive is safe to use with beef cattle and while no health benefit or performance boost was documented, no negative influence was noted either, according to the FDA. Meat from cows fed the supplement also is considered safe for human consumption.
Product use was found to partially reduce manure ammonia gas emissions for an animal or animals in a semi-controlled environment, the agency reported. “The studies did not measure ammonia gas emissions on a herd or farm scale and could not take into account other factors that may affect ammonia gas emissions, such as wind speed and direction, rainfall, weather, input from other nitrogen sources and manure management. Therefore, extrapolation to the herd, farm or larger scale could not be accurately or reliably predicted,” it added.
Product details and uses
The product can be added to feed rations at 1.25 to 4.54g per ton of complete feed or 90% of dry matter basis, Elanco reported. It can be used to provide 13 to 90mg lubabegron per head per day to beef steers and heifers being fed in confinement in the last 14 to 91 days on feed before slaughter.
It can be used to reduce the amount of ammonia gas emitted per pound of live weight or hot carcass weight, the FDA said.
“In the largest study, 336 animals were dosed for 91 days and demonstrated that cumulative NH3 gas emissions were reduced by 14 – 18%,” the FDA said. “To establish the minimum treatment duration of 14 days, a fifth study was conducted, which showed evidence of reduction in NH3 gas emissions during days 7-14. This evidence, along with Day 0-14 data from previous studies, supported the drug’s effectiveness at the minimum duration of 14 days.”
However, the product is not approved for use with breeding animals as the safety and effectiveness have yet to be evaluated, Elanco reported. Horses and other equines should not be allowed access to feed containing the additive.
The product also has been reviewed by the Veterinary Drugs Directorate (VDD) of Health Canada, the FDA reported.