1. Elanco received FDA conditional approval for Credelio Quattro-CA1 for screwworm treatment. 2. Credelio Quattro-CA1 is the first option for treating New World screwworm in pets. 3. The product offers broad parasite coverage, including seven types of parasites. 4. There are 14 confirmed cases of New World screwworm near the U.S.-Mexico border. 5. New options ensure readiness for veterinarians and pet owners against potential infestation.
FAQ
Why Bullish?
The approval of Credelio Quattro-CA1 enhances ELAN's product portfolio, similar to past FDA approvals that positively impacted stock prices. For instance, FDA approvals typically lead to stock price increases as they bolster market confidence and sales potential.
How important is it?
The FDA approval marks a significant milestone for ELAN, enhancing its market position and potentially leading to revenue growth. This is particularly important in a competitive sector where new product development can directly influence stock performance.
Why Short Term?
The immediate impact stems from increased sales potential and market readiness against New World screwworm. Historical examples show that FDA product approvals often lead to short-term price spikes as market sentiment improves.
Elanco Receives FDA Conditional Approval for Credelio Quattro™-CA1 to Combat New World Screwworm in Dogs
Elanco Animal Health Incorporated (NYSE: ELAN) has announced the conditional approval from the U.S. Food and Drug Administration (FDA) for its new product, Credelio Quattro™-CA1, which contains lotilaner, moxidectin, praziquantel, and pyrantel as active ingredients. This marks a significant milestone as it is the first FDA-approved treatment for companion animals specifically targeting infestations caused by New World screwworm larvae.
Expanded Treatment Options for New World Screwworm
Credelio Quattro-CA1 complements the existing Credelio and Credelio CAT products. Both have previously received FDA Emergency Use Authorizations for treating New World screwworm infestations in dogs and cats, respectively. This new approval significantly expands treatment options for veterinarians and pet owners, especially as recent USDA reports indicate multiple cases of New World screwworm detected just 400 miles from the U.S.-Mexico border.
- New World Screwworm Cases: 14 cases reported within 400 miles of the border.
- Proximity of Detection: As close as 70 miles south of the U.S. border.
Dr. Ellen DeBrander's Insights on New Approval
Dr. Ellen DeBrander, Executive Vice President of Research & Development at Elanco, noted, "We appreciate the FDA's commitment to preparing and providing treatment options for New World screwworm in advance of the fly entering the U.S." This approval enhances the Credelio product line's role in animal health.
Efficacy of Credelio Quattro-CA1
The approval is based on robust studies demonstrating the efficacy of lotilaner, the primary active ingredient in Credelio Quattro-CA1. Research published in Parasites & Vectors shows that at the recommended dosage, lotilaner achieves a remarkable 100% efficacy rate against Cochliomyia hominivorax (New World screwworm) larvae in naturally infested dogs within 24 hours of administration.
Seven-in-One Parasite Coverage
Credelio Quattro provides comprehensive protection, covering seven types of parasites, including:
- Ticks
- Fleas
- Heartworm disease
- Roundworms
- Hookworms
- Tapeworms
- Now, New World screwworm
This broad spectrum of coverage is positioned as a valuable asset for veterinarians and pet owners, particularly as the threat of New World screwworm looms closer to U.S. borders.
Preventive Measures and Recommendations
Dr. Casey Locklear, parasitology lead at Elanco, encourages pet owners to closely monitor their dogs for any wounds, as even minor injuries could become entry points for New World screwworm. He advises maintaining year-round parasite protection using Credelio Quattro to help mitigate risks.
About Elanco
Elanco Animal Health (NYSE: ELAN) is a leading animal health company focused on innovating products and services that prevent and treat diseases in both farm animals and pets. With a commitment to advancing animal health for over 70 years, Elanco aims to create valuable solutions for farmers, veterinarians, and pet owners while positively impacting communities worldwide.
Learn More About Credelio Quattro-CA1
For further information about Credelio Quattro and its applications, visit www.elanco.com. Additionally, resources on New World screwworm are available, including:
- Stop Screwworm: Unified Government Response to Protect the United States
- FDA Information for Veterinarians on New World Screwworm
- USDA NWS Alert and Fact Sheet