FDA Approves Elanco Cattle Drug, the First for Reducing Gas Emissions

Xconomy Indiana — 

A product that reduces emissions from farm animal waste? There’s now a drug for that.

The FDA has approved an Elanco (NYSE: ELAN) drug developed to reduce the ammonia gas released from cattle manure. The agency says its Tuesday decision on the product, lubabegron (Experior), marks the first time it has approved a drug that reduces gas emissions from either an animal or its waste.

Agriculture accounted for 9 percent of the country’s greenhouse gas emissions in 2016, the most recent Environmental Protection Agency figures available. The top two sources of U.S. greenhouse gases are transportation and electricity production, with each sector contributing approximately 28 percent of emissions.

For the FDA, approval of the Elanco drug is about more than just reducing greenhouse gases. Ammonia from cattle waste causes noxious odors and atmospheric haze that affect both humans and animals, the FDA says. The emissions can also cause excessive levels of nitrogen and phosphorous in waterways, which lead to algae blooms. In its notice of the drug’s approval, Steven Solomon, the director of the FDA’s Center for Veterinary Medicine, says products such as lubabegron support the agency’s One Health Initiative, which focuses on preventing the spread of animal diseases to humans.

Lubabegron was initially studied for potential applications in human health. The drug, a beta-adrenergic agonist, came from the labs of Elanco’s former parent company, Eli Lilly (NYSE: LLY). Lubabegron binds to and activates a receptor that has the effect of increasing the breakdown of fats and increasing energy expenditure in cells. Lilly researched the compound as a potential treatment for type 2 diabetes and obesity, according to its patent documents. Studies also showed that in animals, the compound’s effects included an improvement in the proportion of feed that the animal can use for bodily functions as well as an increase in lean body mass.

Greenfield, IN-based Elanco picked up the compound for its effects on animals, finding that it could also reduce their ammonia and carbon dioxide emissions. Adjusting cattle diet is one approach taken to reduce such emissions, the company says in its patent filings. But reducing protein intake affects the quality of the meat, resulting in less muscle or muscles that develop slowly. Other strategies for controlling the gases include filters or barriers to prevent the movement of the emissions, but Elanco notes that these approaches are expensive and offer limited benefit.

Elanco tested lubabegron in 536 confined cattle in five studies. In the largest study, which tested 336 animals for 91 days, Elanco reported that ammonia emissions were reduced by between 14 and 18 percent. The FDA notes that these reductions cannot be extrapolated to a herd or a farm because the studies did not measure ammonia gas emissions in those settings, where weather and manure management practices would also affect emissions totals. The Elanco drug did not negatively affect beef production, and the company used experts to evaluate steaks for tenderness, juiciness, and flavors using a 15-point scale.

“Meat tenderness and chewiness were reduced slightly in cattle that received lubabegron compared to the controls, but these differences were minor and unlikely to be noticed by the average consumer,” Elanco said in its drug application.

The FDA approved the Elanco drug for sale over the counter. Elanco will supply it in 10-kilogram bags; the product was developed to be mixed into animal feed. The dosage instructions say the drug is meant to be fed to cattle in the last 14 to 91 days prior to slaughter. The FDA noted that Elanco’s multiple studies indicate that lubabegron is safe for cattle, and meat from cattle treated with the drug is safe to eat. As long as cattle are dosed as directed on the drug’s label, no withdrawal period is required for the cattle.

According to FDA filings, the Elanco drug qualifies for five years of marketing exclusivity because it is the first time the agency has approved this pharmaceutical ingredient in a new animal drug application.

Public domain photo by the U.S. Department of Agriculture