Elanco Launches Pradalex for Treatment of Livestock Respiratory Diseases
by Jennifer Shike, Bovine Veterinarian
Elanco Animal Health Incorporated announced the availability of Pradalex (pradofloxacin injection) for the treatment of swine respiratory disease (SRD) and bovine respiratory disease (BRD).
The first new molecule and injectable antibiotic treatment to be approved by the US Food and Drug Administration (FDA) to treat BRD and SRD in roughly two decades, Pradalex offers livestock producers a new tool in the toolbox.
“SRD is the most prevalent cause of nursery and grow-finish pig deaths in the US, creating substantial production and economic losses for producers and accounting for additional annual costs of up to $5 per pig,” the company said in a release. “In the cattle industry, BRD — or ‘shipping fever’ — is one of the most frequent and costly stocker and feedlot diseases, affecting the health and wellbeing of animals and potentially costing producers $1 billion annually.”
Available in 100 mL and 250 mL volumes, Pradalex is indicated for the treatment of BRD and SRD and kills major BRD and SRD bacteria, including Mannheimia haemolytica , Pasteurella multocida , Histophilus somni , and Mycoplasma bovis in cattle and Bordetella bronchiseptica , Pasteurella multocida , Mycoplasma hyopneumoniae, Glaesserella (Haemophilus) parasuis, and Streptococcus suis in pigs.
“The launch of Pradalex further demonstrates Elanco’s commitment to bring new tools and innovations that help address some of our customers’ biggest challenges,” José Manuel Correia de Simas, executive vice president, US farm animal at Elanco, said in a release. “Pradalex is a new molecule with a novel mode of action that treats respiratory diseases in beef and swine, strengthening our portfolio of solutions and providing veterinarians and producers with multiple choices to prevent and control respiratory challenges.”
The treatment is a convenient single-dose, low-volume antibiotic with “excellent syringeability and an industry-leading withdrawal period,” the company said in a release. Pradalex’s structural differences result in a dual targeting effect that yields improved potency compared to similar antibiotics, Elanco added.
Because Pradalex is rapidly absorbed and distributed at the injection site, it can reach a high and effective therapeutic concentration in plasma within 45 minutes of administration to cattle and a high maximum therapeutic concentration in cattle lung pulmonary epithelial lining fluid within six hours. The company explained this aids in the fast in-vitro elimination of bacteria and limits lung damage in both cattle and swine. Its pharmacokinetic and pharmacodynamic profile reduces the time needed to select resistant bacteria, contributing to judicious antibiotic use, Elanco said.
“Pradalex combines a high plasma peak concentration reached very quickly with a unique mode of action, resulting in comprehensive coverage of Gram-positive and Gram-negative pathogens,” Pat Hoffmann, Elanco swine technical consultant, said in a release. “It makes an exceptional option for a spot treatment injectable intervention.”
Pradalex is indicated for the treatment of:
• SRD in weaned swine intended for harvest
• BRD in beef cattle (calves two months of age and over, steers, heifers, and bulls intended for slaughter and replacement heifers, and bulls intended for breeding and less than one year of age)
• BRD in dairy cattle (replacement heifers and bulls less than one year of age)
Pradalex should not be used in swine intended for breeding (boars intended for breeding, replacement gilts and sows intended for breeding) and in nursing piglets. Pradalex should also not be used in male and female cattle intended for breeding that are over one year of age, in calves under two months of age, or in veal calves.
“At Elanco, we focus on bringing producers a broad portfolio of solutions to support their disease prevention efforts, starting with vaccines and feed additives that optimize the health outcomes of calves,” Ronald Tessman, Elanco beef technical consultant, said in a release. “When antibiotics are necessary, Elanco has a full range to fit producers’ needs. Pradalex is our newest antibiotic and is truly different from any other product on the market, giving producers another valuable tool that can be used in an integrated approach to reducing losses due to BRD.”
