Bayer gets FDA approval for EPM treatment

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Aug 01, 2001
By dvm360.com staff

Shawnee Mission, Kan.- Bayer announces it has received approval from the Center of Veterinary Medicine of the Food and Drug Administration (FDA) for Marquis (15 percent w/w ponazuril) Antiprotozoal Oral Paste for the treatment of equine protozoal myeloencephalitis (EPM). Marquis offers equine veterinarians and their clients the first FDA-approved treatment for EPM, combining safety, efficacy and convenience, the company says.

"EPM has caused more concern among veterinarians and horse owners than perhaps any other equine disease in recent memory," says John Payne, senior vice president with Bayer. "Because exposure to the disease is so widespread among the equine population and because the resulting neurological problems are so devastating, Bayer committed extensive research and development efforts over the past three years toward finding a treatment of EPM that is safe, effective and convenient."

The active ingredient in Marquis in ponazuril, an anticoccidial compound with cidal activity against Sarcocystis neurona, the protozoal parasite that causes EPM. It acts against the parasite at several different stages of the life cycle. Ponazuril crosses the blood/brain barrier to reach the central nervous system (CNS) where damage from EPM occurs.

With Marquis, equine veterinarians can offer their clients a treatment with a once-daily dosage of just 5 mg/kg, which is administered for 28 days. The product is packaged with a reusable plunger and a calibrated dosing ring that assures dosing accuracy, the company says.

"EPM is a debilitating and often fatal disease. Accurate diagnosis can be challenging even for the most experienced clinicians. Until now, current therapies were not approved for the treatment of EPM and some of these treatments have legitimate safety issues, says Dr. Kenton Morgan, senior technical services veterinarian with Bayer. "Marquis will offer the veterinarian and horse owner a product that is safe, efficacious and convenient."

EPM is considered the leading cause of neurological disease in horses in the United States. Almost every region in the country now has reported cases of EPM, the company says. The clinical signs of EPM can vary between horse to horse, because actual signs are related to the location and severity of the lesions that randomly develop in the animal's central nervous system, the company says.

"We believe that education plays a key role in the diagnosis and treatment of this disease," says Allyn Mann, Bayer equine products manager. "In addition to offering Marquis, Bayer will be providing educational tools to equine veterinarians that provide crucial information on EPM including prevention, accurate diagnosis, proper treatment and therapy."

Bayer has established Web sites for veterinarians (www.EPMnews.com) and clients (www.EPMinfo.com) that will offer up-to-date findings, research and information on Marquis and the disease itself.

For more information on Marquis, contact Bayer Animal Health at (800) 633-3796.