- Credelio Quattro™ (lotilaner, moxidectin, praziquantel, and
pyrantel chewable tablets) is the first and only canine oral
parasiticide to protect against six parasites, including fleas,
ticks, heartworms, roundworms, hookwormsii and three
different species of tapeworm that other brands skip creating a gap
in coverageiii
- Warming temperatures and changing consumer habits have
increased parasite pressure and spread across geographies, bringing
with them increased public health risk.
- Experts recommend monthly treatment for zoonotic
parasitesiv, like Echinococcus granulosus, a type
of tapeworm.
- Credelio Quattro launch expected in first quarter of 2025
GREENFIELD, Ind., Oct. 7, 2024
/PRNewswire/ -- Elanco Animal Health Incorporated (NYSE: ELAN)
today announced the U.S. Food and Drug Administration (FDA) has
approved Credelio Quattro™ (lotilaner, moxidectin, praziquantel,
and pyrantel chewable tablets), becoming the broadest approved
canine oral parasiticide with its protection against six types of
parasites—fleas, ticks, heartworms, and the three risky intestinal
parasites—roundworms, hookwormsii and tapeworms.
Credelio Quattro is a single, monthly chewable tablet for dogs
eight weeks of age or older.
"Today is another milestone in Elanco's historic era of
innovation, with the third of three approvals for blockbuster
potential products in the U.S. this year. More importantly, we're
bringing veterinarians and pet owners the broadest parasite
protection by covering six types of parasites in a monthly chewable
tablet," said Jeff Simmons,
President and CEO, Elanco Animal Health. "As pets have become such
an integral part of the family, we're pleased to offer
veterinarians and pet owners a first-of-its-kind solution that
protects against some of the most dangerous parasites that can
spread disease to both pets and people."
Credelio Quattro is the newest addition to the
Credelio® (lotilaner) franchise and the first
FDA-approved parasiticide product with four active ingredients.
Credelio Quattro:
- Starts to kill ticksv and fleas in just 4
hours.
- Kills >99% of fleas within 8 hours of administration and
100% in the first day and remains effective for an entire
month.
- Provided 100% protection from heartworm disease from the first
monthly dose in laboratory studies.
- Contains lotilaner that kills ticksvi twice as
fastvii as sarolaner in Simparica Trio®
and afoxolaner in NexGard®viii.
- Is gentle enough for puppies as small as 3.3 pounds and as
young as 8 weeks.
- Comes in a tasty beef-flavored, easy-to-administer
chewable.
- Provides coverage against internal parasites with zoonotic
potential, meaning parasites that have the potential to infect
people as well as pets, including echinococcus tapeworm.
"Zoonotic disease is more common than many might think. One of
our own Elanco veterinarians recently found echinococcus tapeworm
lurking in her back yard," said Dr. David
Gosche, veterinarian and U.S. Pet Health Medical Director at
Elanco. "Zoonotic disease affects millions of people and animals
worldwide each year. Our pets can easily serve as the 'bridge
hosts,' bringing these parasites into our homes when they cuddle
with us on couches or in our beds—making it very easy to go from
'ick' to 'sick.' That's why we recommend year-round treatment with
the broad spectrum parasite protection in Credelio Quattro."
Hear more from Dr. Elise
Kelly, Elanco veterinarian, who found tapeworm in her
backyard. https://elanco.wistia.com/medias/zdwym2swei
Credelio Quattro joins Elanco's broad portfolio of
parasiticides, including Seresto® and the
Advantage® family, to provide veterinarians and pet
owners with an innovative new solution while also offering a wide
range of products at a variety of price points where consumers
choose to shop. Elanco expects Credelio Quattro to launch in the
first quarter of 2025. Learn more about Credelio Quattro at
CredelioQuattroVet.com.
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.
Indications
Credelio Quattro is indicated for the prevention of heartworm
disease caused by Dirofilaria immitis and for the treatment
and control of roundworm (immature adult and adult Toxocara
canis and adult Toxascaris leonina), hookworm (adult
Uncinaria stenocephala), and tapeworm (Dipylidium
caninum, Taenia pisiformis, and Echinococcus
granulosus) infections. Credelio Quattro kills adult fleas and
is indicated for the treatment and prevention of flea infestations
(Ctenocephalides felis) and the treatment and control of
tick infestations [Amblyomma americanum (lone star
tick), Dermacentor variabilis (American dog tick), Ixodes
scapularis (black-legged tick), and Rhipicephalus
sanguineus (brown dog tick)] for one month in dogs and puppies
8 weeks of age and older and weighing 3.3 pounds or greater.
Important Safety Information
Lotilaner, an ingredient in Credelio Quattro, belongs to the
isoxazoline class and has been associated with neurologic adverse
reactions like tremors, ataxia, and seizures even in dogs without a
history of seizures. Use with caution in dogs with a history of
seizures or neurologic disorders. Dogs should be tested for
existing heartworm infections before Credelio Quattro
administration as it is not effective against adult D.
immitis. The safe use in breeding, pregnant, or lactating dogs
has not been evaluated. The most frequently reported adverse
reactions in clinical trials were vomiting and diarrhea. For full
prescribing information see Credelio package insert.
NexGard is a registered trademark of Boehringer Ingelheim Animal
Health USA Inc. Simparica TRIO is a registered trademark
of Zoetis Services LLC.
Credelio Quattro, Elanco and the diagonal bar logo are
trademarks of Elanco or its affiliates. Other company and product
names are trademarks of their respective owners. © 2024 Elanco or
its affiliates.
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 Credelio
Quattro as product for canine parasite protection, the timeline for
launch, commercial uptake, as well as future studies, publications
and other milestones related to Credelio Quattro, and reflects
Elanco's current beliefs and expectations. However, as with any
animal health pharmaceutical product, there are substantial risks
and uncertainties in the process of drug research, development, and
commercialization. Among other things, there is no guarantee that
planned or ongoing studies will be completed as planned, that
future study results will be consistent with study results to date,
that future studies will receive regulatory approval, or that
Elanco will execute its strategy as expected. For further
discussion of these and other risks and uncertainties that could
cause actual results to differ from Elanco's expectations, see
Elanco's Form 10-K and Form 10-Q filings with the United States
Securities and Exchange Commission. Except as required by law,
Elanco undertakes no duty to update forward-looking statements to
reflect events after the date of this release.
i Based on label comparison of number of
parasite types covered.
ii Uncinaria stenocephala
iii
NexGard® Plus package insert. Duluth,
GA: Boehringer Ingelheim Group; 2023; Simparica Trio®
package insert. Kalamazoo, MI:
Zoetis Inc.; 2022; Credelio Quattro package insert. Greenfield, IN: Elanco Animal Health;
2024.
iv CAPC CAPC Echinococcus spp 2022 (v2.0).
Available at: https://capcvet. org/guidelines/echinococcus-spp/.
Accessed Jul 19, 2023.
v Ixodes
ricinus
vi Amblyomma americanum (lone
star tick)
vii Based on the time to statistical
significance vs control in a single study on Day 21 and Day 28 for
reinfestations. The study compared Credelio™ (lotilaner)—not
Credelio Quattro™, which contains lotilaner as well as moxidectin,
praziquantel, and pyrantel—to the active ingredients in Simparica
Trio™ (sarolaner, moxidectin, and pyrantel) and NexGard™
(afoxolaner).
viii Reif KE, Kollasch TM, Neilson JC, Herrin BH, Ryan
WG, Bell MC, Beltz MS, Dryden MW, Jesudoss Chelladurai JRJ, Miller
KR, Sutherland CJ. Comparative speed of kill provided by lotilaner
(Credelio™), sarolaner (Simparica Trio™), and afoxolaner (NexGard™)
to control Amblyomma americanum infestations on
dogs. Parasite Vectors. 2024 Jul 20;17(1):313.
Investor Contact: Katy Grissom
(317) 273-9284 kathryn.grissom@elancoah.com
Media Contact: Season Solorio (765)
316-0233 season.solorio@elancoah.com
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SOURCE Elanco Animal Health