Recently, the U.S. Food and Drug Administration (FDA) conditionally approved the first pancreatitis treatment for dogs.
On November 15, the FDA approved Panoquell-CA1 for “…management of clinical signs associated with acute onset of pancreatitis in dogs.” Panoquell is an injection drug intended to be used during hospitalization.
What Is Pancreatitis?
Pancreatitis is an inflammatory disease that can threaten a dog’s life and consistently require hospitalization. Common factors for pancreatitis include drastic diet changes—particularly fatty foods—and certain medications. A previous history of diseases like diabetes mellitus can also be a factor.
As pancreatitis is a gastrointestinal disease, symptoms usually show up there as well. Bloating, loss of appetite, diarrhea, and vomiting are just a few symptoms to watch out for.
The First Treatment of Its Kind
According to Steven M. Solomon, director of the FDA’s Center for Veterinary Medicine, Panoquell is “the first drug to address a serious and life-threatening disease that previously could only be managed through supportive care…”.
Following that, Dr. Solomon said, “The conditional approval pathway allows [Panoquell] to reach the marketplace more quickly, and in this case gives dogs…earlier access to a drug to manage this disease.”
With conditional approval, the FDA has made the drug accessible to veterinarians. During life-threatening or critical situations, drugs like Panoquell can save a dog’s life. However, the license only lasts a year, with the possibility to renew it four more times. This being the case, the drug sponsor must provide “substantial evidence of effectiveness for full approval.”
Interestingly, the active ingredient in Panoquell has already treated dogs for years. In 2018, Japan approved Panoquell to help treat pancreatitis. During its assessment of conditional approval, the FDA reviewed data from Japan regarding the drug’s efficacy.
As such, it’s not surprising that Panoquell’s conditional approval was granted to a Japanese manufacturer, Ishihara Sangyo Kaisha Ltd. Hopefully, the treatment will improve many dogs’ health.
