FDA grants first emergency use authorization for NWS treatment in dogs

INDIANAPOLIS - The U.S. Food and Drug Administration (FDA) has issued its first-ever Emergency Use Authorization (EUA) for the treatment of New World screwworm (NWS) infestations in dogs, Elanco Animal Health Incorporated (NYSE:ELAN) announced today. The announcement comes as Elanco, an $11 billion market cap animal health company, continues to show strong market performance, with its stock up over 126% in the past six months. According to InvestingPro data, the company maintains healthy financials with $4.48 billion in revenue over the last twelve months.

The authorization allows Credelio (lotilaner), an oral flea and tick medication, to be used for treating NWS infestations in dogs, providing veterinarians and pet owners with a treatment option before the parasite potentially enters the United States. Confirmed cases of NWS have been detected less than 70 miles south of the U.S.-Mexico border.

NWS infestations occur when female flies lay eggs in open wounds of warm-blooded animals. Unlike most fly species, NWS larvae burrow into living tissue, causing severe damage and potentially death if untreated.

"This first ever Emergency Use Authorization for NWS in dogs gives veterinarians and pet owners peace of mind, knowing there’s an authorized treatment option available as soon as they may need it," said Dr. Ellen de Brabander, Executive Vice President of Innovation and Regulatory Affairs at Elanco, according to the press release.

The EUA was based on a peer-reviewed study published in Parasites & Vectors, which showed oral administration of Credelio at the minimum recommended dosage demonstrated 100% efficacy against NWS larvae within 24 hours of treatment in naturally infested dogs in Brazil.

The FDA noted limitations to the supporting data, including the small study size of eleven dogs and the lack of a control group.

Health officials recommend preventing wounds that could attract NWS flies. The U.S. Animal Plant Health Inspection Service suggests protecting pets from wound-causing parasites like fleas and ticks as one preventive measure against NWS infestations.

Credelio will remain authorized for NWS treatment for the duration of the FDA’s emergency declaration unless terminated earlier. With the stock trading near its 52-week high and analysts predicting continued profitability, investors seeking detailed analysis can access comprehensive research reports and 13 additional ProTips through InvestingPro, which provides in-depth coverage of Elanco and 1,400+ other US stocks.

In other recent news, Elanco Animal Health Incorporated has made significant strides in its financial and product performance. The company announced that its Credelio Quattro product reached a $100 million sales milestone in less than eight months, marking it as Elanco’s fastest-growing pet health product. Additionally, Moody’s Ratings upgraded Elanco’s corporate family rating to Ba2, reflecting improved product uptake and ongoing debt reduction. S&P Global Ratings also upgraded Elanco to ’BB’ from ’BB-’, citing the company’s commitment to reducing leverage, achieved through substantial debt repayment.

JPMorgan upgraded Elanco’s stock to Overweight, noting the company’s entry into an "attractive innovation cycle" with key products like Credelio Quattro gaining market traction. Stifel also raised its price target for Elanco to $23.00, highlighting the strong growth of Credelio Quattro, which is expected to significantly contribute to revenue growth. These developments underscore Elanco’s strategic focus on innovation and financial stability.

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