Feb 3, 2023
Chronic kidney disease (CKD) is a widespread condition that affects an estimated 37 million people in the United States. A common complication of CKD is anemia, a condition characterized by a decreased number of red blood cells. Anemia can have a significant impact on a person's quality of life, leading to fatigue, weakness, and decreased physical activity.
Today, the U.S. Food and Drug Administration (FDA) approved the first oral treatment for anemia caused by chronic kidney disease in adults on dialysis - Jesduvroq tablets (daprodustat). This new drug offers a convenient and effective option for patients with CKD, who previously had to rely on injected treatments.
"With an oral drug option in addition to the FDA-approved injection options, adults with chronic kidney disease on dialysis now have multiple ways to treat their anemia," said Ann Farrell, M.D., director of the Division of Non-Malignant Hematology in the FDA's Center for Drug Evaluation and Research. "This approval demonstrates the FDA's commitment to helping bring a range of therapeutic options to patients with chronic diseases. Patients can consult with their healthcare providers to select the option that is most appropriate."
Jesduvroq increases erythropoietin levels, a hormone produced by the kidneys that signals the body to make red blood cells. In patients with CKD on dialysis, the kidneys are unable to produce enough erythropoietin, leading to anemia. The effectiveness of Jesduvroq was established in a large-scale study of over 2,000 adults receiving dialysis, where patients received either oral Jesduvroq or injected recombinant human erythropoietin (a standard of care treatment for anemia due to CKD). The results showed that Jesduvroq raised and maintained hemoglobin levels within the target range, similar to that of the injected treatment.
Jesduvroq has a boxed warning for an increased risk of thrombotic vascular events, including death, heart attack, stroke, and blood clots in the lungs, legs, or dialysis access site. Additionally, patients using Jesduvroq may be at risk of hospitalization for heart failure, worsening increase of blood pressure, and stomach erosions and gastrointestinal bleeding. Patients should not use Jesduvroq if they also take certain drugs that cause increased levels of Jesduvroq or if they have uncontrolled high blood pressure.
The most common side effects of Jesduvroq include high blood pressure, thrombotic vascular events, abdominal pain, dizziness, and allergic reactions. Patients should consult with their healthcare providers to discuss any side effects they may experience while taking Jesduvroq.
Jesduvroq is approved for adults with anemia caused by chronic kidney disease who have been receiving dialysis for at least four months. It is not approved for patients who are not on dialysis, as its safety has not been established in that population.
The FDA's approval of Jesduvroq is a major step forward in the treatment of anemia caused by chronic kidney disease. With the addition of an oral drug option, patients now have multiple ways to treat their anemia, making it easier and more convenient for them to manage this condition. Jesduvroq is a product of GlaxoSmithKline LLC and is now available for patients to use under the guidance of their healthcare providers.
Rich Foreman brings over 30 years of technology leadership to his role of CEO and Co-Founder of KidneySoft. As founding CTO, Rich led the team that developed the CordicoShield / CordicoFire Wellness App. Cordico was honored with the Sacramento Innovation Award in 2021. After achieving a 7 digit ARR, Cordico was acquired by Lexipol in 2020. Rich has a BS in Industrial Engineering from the University of Washington, an MPA from Troy State University and was an officer in the U.S. Navy. Rich co-authored his book, "Tap into the Mobile Economy." Rich's blog was listed in Top 20 Marketing Mobile Blogs of 2014. He has been featured on KCRA3, NEWS10, 1170 Tech AM PowerDrive, Business Radio Money 105.5, SiliconIndia, the Sacramento Business Journal, and the Sacramento Bee. Rich is also the Founding Director of the Sacramento Chapter of Startup Grind and served a term as Utility Commissioner for the City of Folsom. Rich is a regular contributor to TechWire.net and StartupSac. Rich was the Co-founder of Apptology which was named Small Business of the Year in 2014 by the Sacramento Asian Pacific Chamber. He was also the Founding Chief Technology Officer at Cordico. Cordico was acquired by Lexipol in 2020. Rich also served 4 years as a Naval Officer in the Civil Engineer Corps.
This material is for informational purposes only. It does not replace the advice or counsel of a doctor or health care professional. KidneyLuv makes every effort to provide information that is accurate and timely, but makes no guarantee in this regard. You should consult with, and rely only on the advice of, your physician or health care professional.