Washington, DC, July 06, 2023 (GLOBE NEWSWIRE) -- Patient advocacy organization UsAgainstAlzheimer’s today hailed the first-of-its-kind traditional approval by the Food and Drug Administration (FDA) of lecanemab (marketed as Leqembi), a treatment for early-stage Alzheimer’s. This historic development brings a treatment option and renewed hope for continued innovation to the millions of patients affected by this devastating condition, particularly women and communities of color who face disproportionate rates of the disease. UsAgainstAlzheimer’s celebrated the news and reiterated its call for immediate access to the treatment.
“Leqembi’s traditional approval is a ray of hope for millions of patients who are doing everything in they can to enhance and extend their lives and reduce their families’ burdens,” said George Vradenburg, chairman and co-founder of UsAgainstAlzheimer’s. “People with early-stage disease now have a weapon to fight Alzheimer’s. Finally, we have a drug that can slow the encroachment of Alzheimer’s into our families’ lives and livelihoods.
“The clarification in the label of which a segment of the Alzheimer’s population—about 15%—has an increased risk of side effects should allow patients and their doctors to have a better-informed conversation, tailored to the particular patient’s situation. We applaud the company’s commitments to develop and report information about the experience of patients using Leqembi so that the community can continue to learn,” Vradenburg said.
A large and robust clinical trial has demonstrated Leqembi’s benefit in slowing cognitive and functional decline for patients in the early stages of the disease. While this decision is unquestionably welcome news for people living with disease, attention now turns to the Centers for Medicare & Medicaid Services (CMS) to fulfill their public commitment to provide broad coverage for the treatment.
“The scientists at FDA are in the best position to determine whether a drug is safe and effective. Now that FDA has made their decision, it is not appropriate for CMS to second-guess that decision,” said Stephanie Monroe, UsAgainstAlzheimer’s Vice President and Senior Advisor for Health Equity. “We urge them to keep their word and provide coverage for Leqembi for all populations, including those in the black and brown community disproportionally impacted by Alzheimer’s. Timely and comprehensive access to this therapy is essential for all individuals in need.”
Concerns remain regarding CMS’s unprecedented decision to require participation in a drug registry as a price for meaningful access to treatment. Historically, registries have severely limited patient access and imposed time and cost burdens on physicians.
###
About UsAgainstAlzheimer’s
UsAgainstAlzheimer’s is engaged in a relentless pursuit to end Alzheimer’s, the sixth leading killer in America. Our work centers on prevention, early detection and diagnosis, and access to treatments – all regardless of gender, race, or ethnicity. To achieve our mission, we give voice to patients and caregivers while partnering with government, scientists, the private sector, and allied organizations -- the people who put the “Us” in UsAgainstAlzheimer’s.
Eric Conrad UsAgainstAlzheimer's 2028134815 eric.conrad@gmmb.com
