Personalized Medicine at the FDA: The Scope and Significance of Advances in 2019 defines personalized medicine as an area “in which physicians use diagnostic tests to determine which medical treatments will work best for each patient or use medical interventions to alter molecular, often genetic, mechanisms that cause disease or influence response from a patient to certain treatments ”. The report classifies 11 novel therapeutic molecular entities and gene therapy as personalized treatments. Five of these treatments are the first to tackle the root causes of devastating rare diseases. Four more offer new options for cancer patients, and two include FDA labeling that will help patients avoid debilitating and costly side effects. The report also explains how seven newly approved or approved diagnoses will help make the healthcare system more efficient by targeting treatments only to the patients who will benefit from them, sparing the expense and side effects for those who will not.
“Personalized Medicine at the FDA: The Scope and Significance of Advances in 2019 reminds us that personalized medicine offers new hope for patients with devastating illnesses as well as opportunities to avoid prescribing therapies that will be dangerous or ineffective for certain patient populations, ”said Edouard Abrahams, President, PMC.
Ranking 11 of 44 (25%) new therapeutic molecular entities approved by the FDA last year as personalized drugs, this year’s report marks the sixth consecutive year that personalized drugs account for more than 20% of new approvals. agency drugs. These approvals have risen sharply since 2005, when personalized drugs represented only 5% of newly approved therapies.
About the Personalized Medicine Coalition:
The Personalized Medicine Coalition (PMC), which represents innovators, scientists, patients, providers and payers, promotes the understanding and adoption of personalized medicine concepts, services and products to benefit patients and the system health. For more information on PMC, visit www.personalizedmedicinecoalition.org.
Christopher J. Wells
Vice-President, Public Affairs
Coalition for Personalized Medicine
SOURCE Coalition for Personalized Medicine