As one of the 8.3 million Americans living with gout, CreakyJoints patient advocate David Belton of West Virginia spoke candidly about his 20-year struggle with the debilitating condition to a room full of the who’s who in arthritis during the U.S. Food and Drug Administration’s (FDA) advisory committee for arthritis meeting in early November. At the meeting, a committee panel of experts in arthritis, including rheumatologists, a patient with gout, and representatives of the FDA came together to discuss whether a new gout treatment called lesinurad by AstraZeneca is recommended for FDA approval. The panel voted 10-4 in favor of the approval of lesinurad, but only with some safety-specific stipulations put in place.
In a day full of panel experts offering up details regarding the medication’s safety profile and the overall benefits and risks to users, it seemed only appropriate to ask an actual patient on their experience. Enter David—a member of the Global Healthy Living Foundation’s 50-State Network which helps patients share their voice during important state and federal health policy and regulatory discussions on treatment access, safety and overall quality of care.
David took an active role in the committee’s meeting by discussing his painful experience and how participating in a clinical trial where he was treated with lesinurad helped improve his flare ups significantly.
From missing many days at work for years and taking an early retirement, gout has truly affected David’s day-to-day world. Not to mention the treatments he tried over the years lessened the pain “somewhat” but he still experienced severe gout flares. Since treatment with lesinurad, David noted, “It has been over a year now since my last major flare.”
From actively seeking out and participating in a clinical trial for an investigational treatment to then speaking out about his positive experience with it is the ultimate in patient participation. For millions living with gout, David’s successes are what they aim to have for their own condition. By speaking up about his experience, he hopes the same for them: “Hopefully my experience will help to allow this medication (lesinurad) to be approved so other gout sufferers can find the relief that I currently enjoy.”
According to MedPage Today, AstraZeneca has applied for an indication of lesinurad as a second-line treatment (alongside xanthine oxidase inhibitor) for gout-related hyperuricemia, which occurs when there is an unusually high level of a normal waste product called uric acid in the blood. This acid build up in the blood can crystalize in the joints and/or kidneys. In the clinical trial, David was treated with lesinurad in combination with Uloric.
David’s patient perspective on lesinurad had even more meaning than maybe he realized given the safety concerns for lesinurad, including higher rates of death, renal toxicity, and cardiac issues, observed in clinical trials. As gout patients are limited in treatment options that may successfully manage their flares and related symptoms, it was noteworthy to hear David’s perspective on how the treatment helped him, which balanced out the discussions around lesinurad’s safety concerns.
Ultimately, the majority of the panel recommended lesinurad approval with a few key stipulations. These must haves for the panel, included stronger guidelines, conservative and specific drug labeling on the potential serious adverse events and continued research on the treatment post-approval.
While the FDA doesn’t have to go with the recommendations provided by its committees, but usually it does.
Anyone interested in joining the 50-State Network can do that here. By joining, you’ll receive updates on impending legislation at both the national and state levels which could impact your healthcare and the healthcare for millions and how you can actively participate in important conversations.
Update: The FDA approved lesinurad at the lower dose of 200 mg on December 22, 2015.