There‘s a limited gout drug arsenal available. So the drug company Novartis AG saw an opening and went for it. Last month, the company hoped to gain FDA approval for their gout drug called Ilaris.
But their gamble didn‘t work.
The FDA denied approval. (Shocking, I know.)
Ilaris is a serious drug already approved to treat a group of rare inflammatory disorders. Novartis hoped to open it up as a gout drug as well. It appears to decrease gout pain by blocking a protein linked to inflammation.
But this gout drug‘s side effects are more dangerous than gout itself! Taking this gout drug for gout pain would be kinda like lopping off your big toe. Sure...you get rid of the pain in your toe, but what the heck...you‘re also now missing a toe!
In the company‘s study, almost 70 percent of patients had some mild to moderate side effects, including high blood pressure. In addition, 18 of the patients had skin, respiratory and other infections. Six of the volunteers in the study died. Plus, only 43 of the patients even had three or more injections of Ilaris.
Okaaay. And Novartis wants to give this gout drug to the millions of men and women with gout in America?
Thankfully, cooler heads prevailed.
According to Dr. David Felson, a panel member and professor at the Boston University School of Medicine, "I found the safety issues to be overwhelmingly concerning. We‘re giving therapies that in some cases may be life-threatening for a disease that is not. Forty-three patients with recurrent treatment is too small a number for us to be confident that this would be safe for people over time."
Interestingly, Dr. Felson hails from BU School of Medicine. This is where they conducted the research on vitamin C, cherries, and gout. No doubt, this played a role in Dr. Felson‘s decision.