June 9, 2009

The Food and Drug Administration announced today the approval of Felimazole (methimazole), a new drug for the treatment of hyperthyroidism in cats.

Felimazole, a new molecular entity for animals, is the first drug approved for hyperthyroidism in cats. Hyperthyroidism is caused by an increase in production of thyroid hormones from the thyroid glands. Methimazole is an antithyroid drug and works by blocking the creation of thyroid hormones.

"Hyperthyroidism is one of the most common diseases seen in middle-aged and senior cats," said Bernadette Dunham, D.V.M., Ph.D., director of FDA's Center for Veterinary Medicine. "Cats can become seriously ill with this condition. The approval of Felimazole offers cat owners, in consultation with their veterinarians, an effective medical treatment for this serious disease.”

Thyroid hormones play an important role in controlling the body’s metabolic rate. Hyperthyroid cats generally have weight loss, despite increased appetite and food intake. The disease can also cause increased thirst, hyperactivity, rapid heart rate and irritability. Left untreated, the disease can result in heart failure or high blood pressure.

The effectiveness and safety of Felimazole were evaluated in field studies conducted in the United Kingdom and the United States. Success was measured by a decrease in the production of thyroid hormones or T4 levels and improvement in clinical signs, i.e., weight gain, no longer vomiting, return to normal eating habits, etc. A total of 166 hyperthyroid cats were treated with Felimazole. By day 42, 77% of cats in the UK study had normal T4 levels and 81% had reduced disease severity. In the US study, by day 42, 61% of cats were considered treatment successes with a significant decrease in T4 concentration and improved clinical signs. The most common side effects associated with Felimazole included a change in food consumption (increase or decrease), lethargy, vomiting, and diarrhea. Less common side effects include anemia and low platelet count in some cats.

Felimazole is manufactured by Dechra, Ltd., Staffordshire, United Kingdom. For more information, please see the FOI summary.

http://www.fda.gov/downloads/AnimalVeterinary/Products/ApprovedAnimalDrugProducts/FOIADrugSummaries/UCM165091.pdf

  First Drug to Treat Cancer in Dogs Approved

FDA NEWS RELEASE

June 3, 2009

  The U.S. Food and Drug Administration today announced the approval of Palladia (toceranib phosphate), the first drug developed specifically for the treatment of cancer in dogs. Palladia is approved to treat canine cutaneous (skin-based) mast cell tumors, a type of cancer responsible for about 1 out of 5 cases of canine skin tumors. The drug is approved to treat the tumors with or without regional lymph node involvement.

All cancer drugs now used in veterinary medicine originally were developed for use in humans and are not approved for use in animals. Cancer treatments used in animals are used in an “extra-label” manner as allowed by the Animal Medicinal Drug Use Clarification Act of 1994.

"This cancer drug approval for dogs is an important step forward for veterinary medicine," said Bernadette Dunham, D.V.M., Ph.D., director of FDA's Center for Veterinary Medicine. "Prior to this approval, veterinarians had to rely on human oncology drugs, without knowledge of how safe or effective they would be for dogs. Today's approval offers dog owners, in consultation with their veterinarian, an option for treatment of their dog's cancer."

While canine mast cell tumors often appear small and insignificant, they can be a very serious form of cancer in dogs. Some mast cell tumors are easily removed without the development of any further problems, while others can lead to life threatening disease. Palladia is a tyrosine kinase inhibitor and works in two ways: by killing tumor cells and by cutting off the blood supply to the tumor. In a clinical trial, Palladia showed a statistically significant difference in tumor shrinkage when compared with an inactive substance (placebo).

The most common side effects associated with Palladia are diarrhea, decrease or loss of appetite, lameness, weight loss, and blood in the stool. Palladia is manufactured by Pfizer Animal Health Inc., New York City.