Drugs treating epilepsy, feline diabetes receive FDA approval
September 18, 2023
The Food and Drug Administration (FDA) has recently approved a number of animal drugs, including those that treat idiopathic epilepsy in dogs and diabetes in cats.
Fidoquel-CA1 for dogs
On September 6, the FDA conditionally approved Fidoquel-CA1, or phenobarbital tablets, for the control of seizures associated with idiopathic epilepsy in dogs. Idiopathic epilepsy is a type of seizure disorder without a known cause and is a serious or life-threatening condition that affects approximately 5% of dogs.
The antiepileptic drug is available by prescription from a licensed veterinarian and is given orally twice a day at the minimum dosage of 2.5 mg/kg and may be adjusted to a maximum dosage of 5 mg/kg.
Phenobarbital tablets from the human drug market have historically been used off label in veterinary medicine to help control seizures in dogs, according to the FDA.
Conditional approval means that, when used according to the label, the drug is safe and has a reasonable expectation of effectiveness. The drug sponsor must meet the requirements for substantial evidence of effectiveness within five years for full approval.
Fidoquel-CA1 is the second drug to receive FDA approval to treat dogs with idiopathic epilepsy. The agency conditionally approved KBro Vet-CA1 (potassium bromide) in 2021.
Among the possible adverse effects are lethargy or sedation, lack of coordination, hunger, frequent urination, and thirst.
Fidoquel-CA1 is sponsored by Genus Lifesciences Inc., based in Allentown, Pennsylvania.
Senvelgo for cats
On August 10, the FDA approved Senvelgo, an avelagliflozin oral solution, for improving glycemic control in otherwise healthy cats with diabetes mellitus not previously treated with insulin.
Senvelgo is a liquid medication for diabetes in cats that is administered to cats once daily, with or without food. The approved dosage is 1 mg/kg of body weight, once daily, and regardless of blood glucose level.
Velagliflozin, a sodium-glucose cotransporter 2 (SGLT2) inhibitor, works by reducing the reabsorption of filtered glucose in the kidneys, resulting in increased glucose excretion in the urine.
Historically, diabetes mellitus has been managed with insulin injections, commonly administered twice daily. Cats requiring twice daily insulin require close monitoring of blood glucose levels.
Dr. Colleen Currigan, medical director of the VCA Cat Hospital of Chicago, explained that daily timed insulin administration can be problematic for many owners, such as those with disabilities, skittish cats, heavy travel schedules, and others who are not reliably available to give daily insulin.
“Senvelgo is truly a game-changer drug that has the potential to revolutionize the way we can now manage feline diabetes,” Dr. Currigan said. “Experience in patients thus far with the SGLT2 inhibitors has been very positive.”
Additionally, the ease of administration and success of this drug in treating the disease makes it an attractive alternative to insulin for many newly diagnosed diabetics, she said.
“Any time a medication can effectively treat a disease with ease of administration, it helps to keep the human-animal bond strong,” Dr. Currigan added.
Senvelgo is supplied in a 45 mL plastic bottle and is available by prescription from a licensed veterinarian. It will be available in the U.S. by mid-October. The company plans to launch the drug in other countries, pending regulatory approvals.
Senvelgo is sponsored by Boehringer Ingelheim, based in Duluth, Georgia.