{"id":159321,"date":"2021-06-07T12:00:26","date_gmt":"2021-06-07T16:00:26","guid":{"rendered":"https:\/\/breaking911.com\/?p=159321"},"modified":"2021-06-07T12:02:35","modified_gmt":"2021-06-07T16:02:35","slug":"breaking-fda-approves-aduhelm-first-new-drug-for-alzheimers-in-20-years","status":"publish","type":"post","link":"https:\/\/breaking911.com\/breaking-fda-approves-aduhelm-first-new-drug-for-alzheimers-in-20-years\/","title":{"rendered":"FDA approves Aduhelm, first new drug for Alzheimer’s in 20 years"},"content":{"rendered":"

WASHINGTON – (FDA)<\/em> – Today, the U.S. Food and Drug Administration approved Aduhelm (aducanumab) for the treatment of Alzheimer\u2019s, a debilitating disease affecting 6.2 million Americans. Aduhelm was approved using the\u00a0accelerated approval pathway<\/a>, which can be used for a drug for a serious or life-threatening illness that provides a meaningful therapeutic advantage over existing treatments. Accelerated approval can be based on the drug\u2019s effect on a surrogate endpoint that is reasonably likely to predict a clinical benefit to patients, with a required post-approval trial to verify that the drug provides the expected clinical benefit.<\/p>\n

\u201cAlzheimer\u2019s disease is a devastating illness that can have a profound impact on the lives of people diagnosed with the disease as well as their loved ones,\u201d said Patrizia Cavazzoni, M.D., director of the FDA\u2019s Center for Drug Evaluation and Research. \u201cCurrently available therapies only treat symptoms of the disease; this treatment option is the first therapy to target and affect the underlying disease process of Alzheimer\u2019s. As we have learned from the fight against cancer, the accelerated approval pathway can bring therapies to patients faster while spurring more research and innovation.\u201d<\/strong><\/p>\n