New Kidney Drug Therapy and the FDA
The American Association of Kidney Patients, the largest kidney patient consumer and caregiver organization in the nation, today issued the following statement regarding the recent approval by the U.S. Food and Drug Administration of a new drug therapy, Kerendia by Bayer Pharmaceuticals, designed to slow chronic kidney disease progression and reduce the risk of kidney failure in adult patients with chronic kidney disease associated with type 2 diabetes. Since its founding in 1969, AAKP has been the leading independent and patient-led voice for greater investments and innovations in kidney disease research, detection, and treatment. AAKP is nationally known for its aggressive advocacy on behalf of kidney patient consumers and their right to treatment care choice in consultation with the doctors who they choose to care for them. AAKP defines high-quality kidney care as timely patient access, without interference, to prevention and treatment innovations that empower patients to remain healthy, independent, and able to pursue their aspirations including meaningful work and a career, home ownership, starting and supporting a family, and a secure retirement.
FDA Approval Of Kerendia
“The American Association of Kidney Patients, as the largest kidney patient organization in the nation, applauds the recent FDA approval of Kerendia because of the substantial medical advancement and hope it represents for kidney patient consumers and their decades-long demand for more innovations to help slow the impacts of chronic kidney disease associated with type 2 diabetes, including loss of kidney function and kidney failure. Kidney disease has an incredibly alarming, growing, and disproportionate impact among minority communities and the burdens and costs are carried by patients, their families, and the American taxpayer. We look forward to informing elected leaders, government agencies, and payers that timely access to this treatment, when determined to be medically beneficial and safe between doctors and their patients, is a priority. Unnecessary interference with these medical determinations or delays with patient access are inconsistent with the principle of patient care choice and the long-standing national goal of advancing innovations and new tools to slow kidney disease, reduce kidney failure, and decrease the number of Americans who may end up on dialysis or the kidney transplant waiting list.”
Working with the FDA
AAKP works closely with federal government officials, medical researchers, industry leaders, and investors who are committed to re-establishing kidney patient consumers to their rightful place at the center of all kidney health, innovation, research, and policy decisions. The organization provides original kidney patient survey data and expert advice to leaders in government, industry, think tanks, and academia involved in standing up and recruiting patients for research studies, technical evaluation panels, advisory committees, clinical trials, and substantive efforts to include patient insight data across the product development lifecycle —including regulatory and payment decisions.
In 2019, AAKP launched The Decade of the Kidney™, an international patient consortium aimed at mobilizing patient consumers and their allies to push leaders and decision-makers for greater investments in kidney research and more sensible policies to accelerate innovations in kidney drugs, diagnostics, and devices, including artificial kidneys. Since 2019, AAKP, in partnership with The George Washington University School of Medicine and Health Sciences, has conducted The Global Summit on Kidney Disease Innovations (watch 2021 sessions OnDemand here), which has become the largest patient-led and virtual global kidney meeting, engaging over eighty countries and 20,000 viewers in 2021. In 2018, AAKP launched their nonpartisan KidneyVoters™ program, the first voter registration effort for kidney patients, their families, and the broader kidney stakeholder community, including medical professionals. Based on the 2020 success of KidneyVoters™, AAKP has announced plans to register a half million patients and kidney advocates by 2024.
About the American Association of Kidney Patients (AAKP): Founded in 1969, AAKP is the largest kidney patient organization driving policy discussions on kidney patient consumer care choice and treatment innovations. By 1973, AAKP patient collaborations with the U.S. Congress and White House helped gain passage of dialysis coverage for any person suffering kidney failure, creating the only disease specific, taxpayer-funded entitlement program in America. That program, the End Stage Renal Disease Program (ESRD) administered by CMS, has saved over one million lives. In the past decade, AAKP patients have helped gain lifetime transplant drug coverage for kidney transplant recipients (2020); new patient-centered policies via the White House Executive Order on Advancing American Kidney Health (2019); new job protections for living organ donors under the Family Medical Leave Act (FMLA) from the U.S. Department of Labor (2018); and Congressional legislation allowing HIV-positive organ transplants for HIV-positive patients (2013). AAKP virtual platforms and social networks are internationally known for their impact. Follow AAKP on social media at @kidneypatient on Facebook and @kidneypatients on Twitter and visit our website at https://aakp.org/.
SOURCE American Association of Kidney Patients
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