A Review of FDA PRO Labeling ( ) Ari Gnanasakthy RTI Health Solutions
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1 A Review of FDA PRO Labeling ( ) Ari Gnanasakthy RTI Health Solutions SEVENTH ANNUAL PATIENT-REPORTED OUTCOME (PRO) CONSORTIUM WORKSHOP April 27-28, 2016 Silver Spring, MD
2 Disclaimer The views and opinions expressed in the following slides are those of the individual presenters and should not be attributed to their respective organizations/companies, the U.S. Food and Drug Administration, the Critical Path Institute, the PRO Consortium, or the epro Consortium. These slides are the intellectual property of the individual presenters and are protected under the copyright laws of the United States of America and other countries. Used by permission. All rights reserved. All trademarks are the property of their respective owners.
3 Acknowledgements Margaret Mordin Emily Haydysch Carla DeMuro Lynda Doward Sheri Fehnel
4 Review of PRO labeling ( ) 24.1% of new drug approved between 2006 and 2010 had PRO labeling
5 Percent of NMEs with PRO labeling ( ) Total number of new drugs approved = 182 Total number of new drugs with PRO labeling = 30 Percent of new drugs with PRO labeling ( ) = 16.5% n = 116 Percent of new drugs with PRO labeling ( ) = 24.1% n = 182
6 There was noticeable increase in the number of NME approvals for three disease categories Change (%) in NME approvals FDA vs % 135.6% 92.8% 115.4% 56.9% CANCER INFECTIOUS DISEASES ENDOCRINE AND METABOLIC Disease type 5.6% OTHER TOTAL Number of approvals: = 116; =182 Infectious diseases infection and parasitic diseases; Endocrine and metabolic - Endocrine, nutritional and metabolic diseases
7 Only a few labeling in the 3 major diseases in the last 10 years ( ) 40.00% PRO Labeling (FDA NMEs ) N=298; L= % 34.2% 30.00% 25.00% 20.00% 15.00% 10.00% 5.00% 0.00% 3.5% L = 5 L = 53 3 major diseases Other diseases Labeling Number of approvals: = 116; =182 3 major diseases: Neoplasms. infection and parasitic diseases & Endocrine, nutritional and metabolic diseases
8
9 Two categories of diseases PRO Dependent Non PRO Dependent Traditionally depends on PROs to demonstrate treatment benefit
10 Non PRO-Dependent diseases Non PRO Diseases Examples Neoplasms Cancers (breast, ovarian, prostate etc.) Infection and parasitic diseases Tuberculosis of the lungs, HIV disease, Hepatitis C Endocrine, nutritional and metabolic diseases Diabetes, Hypophosphatasia, Familial hypercholesterolemia Diseases of the circulatory system Chronic heart failure, myocardial infarction, pulmonary heart disease Pregnancy, childbirth and the puerperium Spontaneous abortion, obstetric embolism, eclampsia in labor Symptoms, signs and abnormal clinical and laboratory findings Elevated blood glucose level, enlarged lymph nodes, functional quadriplegia Injury, poisoning and certain other conditions of external causes Injury to the head, frostbite, poisoning by overdose of substance External causes of morbidity Transport accidents, intentional self-harm, military operations Factors influencing health status and contact with health services Kidney transplant, smoking cessation, preventive pregnancy Unclassified Imaging agents
11 PRO-Dependent diseases PRO Diseases Examples Blood and blood forming organs Myelofibrosis, Iron deficiency anemia, hereditary angioedema Mental, behavioral and neurodevelopmental disorders Schizophrenia, anxiety disorders, major depressive disorder Diseases of the nervous system Insomnia, epilepsy, multiple sclerosis Diseases of the eye and adnexa Glaucoma, age-related macular degeneration, conjunctivitis Diseases of the ear and mastoid process Otosclerosis, hearing loss, tinnitus Diseases of the respiratory system Asthma, Chronic obstructive pulmonary disease, Idiopathic pulmonary fibrosis Diseases of the digestive system Irritable bowel syndrome, constipation, Ulcerative (chronic) pancolitis Diseases of the skin and subcutaneous system Psoriasis, urticaria, atopic dermatitis Diseases of the musculoskeletal system Osteoarthritis, gout, lupus Diseases of the genitourinary system Erectile dysfunction, overactive bladder, dyspareunia
12 There was a noticeable decrease in the percent of approvals relating to PRO Dependent Diseases NME Approvals (FDA ) 72.5% 57.8% 42.2% 27.5% N = 49/116 N = 50/182 N = 67/116 N = 132/182 Approvals in = 116 Approvals in = 182 PRO DEPENDENT NON PRO DEPENDENT
13 PRO labeling (%) was comparable for the periods and (FDA NMEs) 100% 90% 80% % % 70% 60% 50% 40% % 20% 10% 0% Approvals in = 116 Approvals in = PRO Related Non PRO Related
14 Summary Overall, PRO labeling declined from 24.1% to 16.5% between and Number of new drugs approved that traditionally use PRO related endpoints to assess treatment benefit was about the same between and = = 50 For approvals that traditionally use PRO related endpoints to assess treatment benefit, labeling based on PROs was comparable for the periods and = 46.9% = 46.0%
15 15
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