Elanco Announces Credelio Quattro Moves to Final FDA Administrative Review
Elanco Animal Health Incorporated (NYSE: ELAN) announced that its broad-spectrum parasiticide, Credelio Quattro, has entered the final 60-day FDA administrative review. The company expects U.S. approval in October and plans to launch the product in Q1 2025. Elanco is seeking approval for indications that would provide the broadest parasite coverage, including fleas, ticks, heartworms, and tapeworms.
CEO Jeff Simmons highlighted Elanco's robust innovation portfolio, projecting $600 million to $700 million in innovation sales for 2025. The company is finalizing manufacturing scale-up to optimize the launch. This development follows the completion of Bovaer's review ahead of schedule, with both Zenrelia and Credelio Quattro now in final FDA review, demonstrating Elanco's R&D capabilities.
Elanco Animal Health Incorporated (NYSE: ELAN) ha annunciato che il suo parassiticida a largo spettro, Credelio Quattro, è entrato nella fase finale di revisione amministrativa di 60 giorni da parte della FDA. L'azienda prevede l'approvazione negli Stati Uniti a ottobre e pianifica di lanciare il prodotto nel primo trimestre del 2025. Elanco sta cercando l'approvazione per indicazioni che fornirebbero la copertura parassitaria più ampia, inclusi pulci, zecche, vermi cardiaci e tenie.
Il CEO Jeff Simmons ha messo in evidenza il robusto portafoglio di innovazione di Elanco, prevedendo vendite da innovazione tra i 600 milioni e i 700 milioni di dollari per il 2025. L'azienda sta ultimando l'ampliamento della produzione per ottimizzare il lancio. Questo sviluppo segue il completamento della revisione di Bovaer con largo anticipo, con Zenrelia e Credelio Quattro ora in fase finale di revisione da parte della FDA, dimostrando le capacità di R&D di Elanco.
Elanco Animal Health Incorporated (NYSE: ELAN) anunció que su parásito de amplio espectro, Credelio Quattro, ha entrado en la revisión administrativa final de 60 días de la FDA. La compañía espera obtener la aprobación en Estados Unidos en octubre y planea lanzar el producto en el primer trimestre de 2025. Elanco busca la aprobación de indicaciones que proporcionarían la cobertura de parásitos más amplia, incluidos pulgas, garrapatas, gusanos del corazón y tenias.
El CEO Jeff Simmons destacó el robusto portafolio de innovación de Elanco, proyectando ventas por innovación de entre 600 y 700 millones de dólares para 2025. La compañía está finalizando el aumento de la producción para optimizar el lanzamiento. Este desarrollo sigue a la finalización de la revisión de Bovaer antes de lo previsto, con Zenrelia y Credelio Quattro ahora en la revisión final de la FDA, demostrando las capacidades de I+D de Elanco.
엘란코 애니멀 헬스 주식회사(NYSE: ELAN)는 그들의 광범위한 외부 기생충 약물인 크레델리오 콰트로가 FDA의 60일 행정 리뷰 최종 단계에 들어갔다고 발표했습니다. 회사는 10월에 미국에서 승인을 받을 것으로 예상하고 있으며, 2025년 1분기에 제품을 출시할 계획입니다. 엘란코는 벼룩, 진드기, 심장사상충 및 촌충을 포함한 가장 광범위한 기생충 범위를 제공할 수 있는 적응증 승인을 찾고 있습니다.
CEO 제프 시몬스는 엘란코의 강력한 혁신 포트폴리오를 강조하며 2025년 혁신 매출이 6억에서 7억 달러에 이를 것으로 예상합니다. 회사는 출시를 최적화하기 위해 생산 규모 확대를 마무리하고 있습니다. 이러한 발전은 보바어의 검토가 예정보다 일찍 완료된 후 이루어졌으며, 이제 젠렐리아와 크레델리오 콰트로가 FDA의 최종 검토 단계에 있어 엘란코의 연구개발 능력을 보여주고 있습니다.
Elanco Animal Health Incorporated (NYSE: ELAN) a annoncé que son antiparasitaire à large spectre, Credelio Quattro, est entré dans la phase finale de révision administrative de 60 jours par la FDA. L'entreprise s'attend à une approbation aux États-Unis en octobre et prévoit de lancer le produit au premier trimestre 2025. Elanco cherche à obtenir une approbation pour des indications qui offriraient la couverture parasitaire la plus large, y compris les puces, les tiques, les vers cardiaques et les ténias.
Le PDG Jeff Simmons a souligné le solide portefeuille d'innovation d'Elanco, projetant des ventes d'innovation entre 600 millions et 700 millions de dollars pour 2025. L'entreprise finalise l'augmentation de la production pour optimiser le lancement. Ce développement fait suite à l'achèvement anticipé de la révision de Bovaer, Zenrelia et Credelio Quattro étant désormais en phase finale de révision par la FDA, démontrant ainsi les capacités de R&D d'Elanco.
Elanco Animal Health Incorporated (NYSE: ELAN) hat angekündigt, dass ihr Breitband-Pestizid Credelio Quattro in die finalen 60 Tage der administrativen Überprüfung durch die FDA eingetreten ist. Das Unternehmen erwartet die Genehmigung in den USA im Oktober und plant, das Produkt im ersten Quartal 2025 auf den Markt zu bringen. Elanco strebt die Genehmigung für Indikationen an, die die weitreichendste Abdeckung von Parasiten, einschließlich Flöhe, Zecken, Herzwürmer und Bandwürmer, bieten würden.
CEO Jeff Simmons hob das robuste Innovationsportfolio von Elanco hervor und prognostizierte Innovationsverkäufe von 600 bis 700 Millionen Dollar für 2025. Das Unternehmen finalisiert die Produktionsskalierung, um den Launch zu optimieren. Diese Entwicklung folgt dem vorzeitigen Abschluss der Überprüfung von Bovaer, wobei sowohl Zenrelia als auch Credelio Quattro nun in der finalen FDA-Überprüfung sind, was die F&E-Fähigkeiten von Elanco demonstriert.
- Credelio Quattro has entered final FDA administrative review, indicating progress towards approval
- Expected U.S. approval in October with Q1 2025 launch plans
- Seeking approval for broadest parasite coverage in the market
- Projected $600-$700 million in innovation sales for 2025
- Two potential blockbuster products (Zenrelia and Credelio Quattro) in final FDA review
- None.
Insights
Elanco's Credelio Quattro entering the final FDA review stage signals a significant milestone. This broad-spectrum parasiticide could be a game-changer in the pet care market. With potential approval for the widest range of parasites, including fleas, ticks, heartworms and tapeworms, it may offer a competitive edge over existing products.
The projected
The expedited Bovaer review and simultaneous final reviews for Zenrelia and Credelio Quattro demonstrate Elanco's R&D efficiency, which could be a long-term value driver. This pipeline progress may positively influence investor sentiment, but it's important to monitor actual market performance post-launch.
Elanco's pipeline progress is encouraging, but investors should approach with cautious optimism. The company's projection of
The "potential blockbuster" status (
Investors should focus on Elanco's ability to execute launches effectively and achieve projected sales. While pipeline progress is positive, it's important to monitor the company's overall financial health, including debt levels and profit margins, as R&D investments often pressure short-term profitability.
Company's broad spectrum parasiticide on-track for October
"This is an exciting time at Elanco as we deliver a robust innovation portfolio that we believe will help transform animal care with solutions that go beyond today's market leaders," said Jeff Simmons, Elanco President and CEO. "Elanco expects to launch a potential blockbuster each of the next three quarters in large, fast-growing or new markets that are largely accretive to Elanco. We continue to expect
The Company continues to expect Credelio Quattro to be positively differentiated and is seeking approval for indications that would give the broadest parasite coverage including fleas, ticks, heartworms and other internal parasites, like tapeworm. In addition to the regulatory process, the company is finalizing the manufacturing scale-up to optimize launch, targeted for the first quarter of 2025.
"We are very pleased with the continued progress of our pipeline," said Dr. Ellen de Brabander, Executive Vice President of Innovation and Regulatory Affairs. "We completed the Bovaer review ahead of schedule and now have two potential blockbusters – Zenrelia and Credelio Quattro – in the final administrative review at FDA, illustrating our R&D organization's high capacity and ability to build capabilities to deliver a consistent flow of high impact innovation. A significant thank you to the Elanco team for their efforts to bring these differentiated innovations toward approval while also refilling and advancing the early-stage pipeline for the next era of innovation."
The FDA has the legal authority to approve and regulate drugs for both people and animals. FDA's Center for Veterinary Medicine (CVM) approves and regulates new animal drugs. The approval process includes up to five major technical sections (Target Animal Safety; Effectiveness; Chemistry, Manufacturing, and Controls; Human Food Safety (farm animal products); and Environmental Impact (farm animal products) and two minor technical sections (All Other Information and Labeling)). Once all the major and minor technical sections are complete, the drug sponsor submits the New Animal Drug Application (NADA), for the final administrative review. For more information about the FDA approval process, please visit: https://www.fda.gov/animal-veterinary/animal-health-literacy/idea-marketplace-journey-animal-drug-through-approval-process.
ABOUT ELANCO
Elanco Animal Health Incorporated (NYSE: ELAN) is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our Elanco Healthy Purpose™ sustainability pillars – all to advance the health of animals, people, the planet and our enterprise. Learn more at www.elanco.com.
Cautionary Statement Regarding Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the federal securities laws, including, without limitation, statements concerning product approvals and launches and revenue from such products
Forward-looking statements are based on our current expectations and assumptions regarding our business, the economy and other future conditions. Because forward-looking statements relate to the future, by their nature, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict. As a result, our actual results may differ materially from those contemplated by the forward-looking statements. Important risk factors that could cause actual results to differ materially from those in the forward-looking statements include regional, national or global political, economic, business, competitive, market and regulatory conditions, including but not limited to operating in a highly competitive industry; the success of our research and development (R&D) and licensing efforts; the impact of disruptive innovations; competition from generic products; an outbreak of infectious disease carried by farm animals; risks related to the evaluation of animals; consolidation of our customers and distributors; the impact of increased or decreased sales into our distribution channels; our dependence on the success of our top products; our ability to complete acquisitions and divestitures and successfully integrate the businesses we acquire; our ability to implement our business strategies or achieve targeted cost efficiencies and gross margin improvements; manufacturing problems and capacity imbalances; fluctuations in inventory levels in our distribution channels; the impact of weather conditions, including those related to climate change, and the availability of natural resources; the effects of a human disease outbreak, epidemic, pandemic or other widespread public health concern; the loss of key personnel or highly skilled employees; adverse effects of labor disputes, strikes and/or work stoppages; the effect of our substantial indebtedness on our business; changes in interest rates; risks related to the write-down of goodwill or identifiable intangible assets; the lack of availability or significant increases in the cost of raw materials; risks related to our presence in foreign markets; risks related to currency rate fluctuations; risks related to underfunded pension plan liabilities; the potential impact that actions by activist shareholders could have on the pursuit of our business strategies; actions by regulatory bodies, including as a result of their interpretation of studies on product safety; the possible slowing or cessation of acceptance and/or adoption of our farm animal sustainability initiatives; the impact of increased regulation or decreased governmental financial support related to the raising, processing or consumption of farm animals; the impact of litigation, regulatory investigations, and other legal matters, including the risk to our reputation; challenges to our intellectual property rights or our alleged violation of rights of others; misuse, off-label or counterfeiting use of our products; unanticipated safety, quality or efficacy concerns and the impact of identified concerns associated with our products. For additional information about these and other factors that could cause actual results to differ materially from forward-looking statements, please see the Risk Factors in the company's latest Form 10-K and Form 10-Qs filed with the Securities and Exchange Commission. Although we have attempted to identify important risk factors, there may be other risk factors not presently known to us or that we presently believe are not material that could cause actual results and developments to differ materially from those made in or suggested by the forward-looking statements contained in this press release. Any forward-looking statement made by us in this press release speaks only as of the date thereof. We undertake no obligation to publicly update or to revise any forward-looking statement, whether as a result of new information, future developments or otherwise, except as may be required by law.
Additional Information
We define innovation revenue as revenue from new products, lifecycle management and certain geographic expansions and business development transactions that is incremental in reference to product revenue in 2020 and does not include the expected impact of cannibalization on the base portfolio.
Investor Contact: Kathryn Grissom, +1.317.273.9284, kathryn.grissom@elancoah.com
Media Contact: Colleen Parr Dekker, +1.317.989.7011, colleen.dekker@elancoah.com
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SOURCE Elanco Animal Health
FAQ
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