News & Views: FDA opens, CDRH record-setting year, New Drug Class for Migraines
FDA Opens
CDRH-Record Year for Device Innovation
Success in advancing device innovation and approval/clearance novel, safe and effective technologies
- Approval of 106 novel devices, surpassing the 40-year record we set in 2017 of 99
- Granted 112 Breakthrough Device Designation requests; 9 approved/cleared
Examples of innovative products
- Automated insulin dosing system – including for those as young as age 7
- World’s smallest heart valve for newborns
- First blood test in the world to evaluate mild traumatic brain injury
- First mobile medical app to help treat substance abuse disorders
- Artificial Intelligence to detect diabetic retinopathy in adults
- Artificial Intelligence to detect wrist fractures
- First artificial iris
New Drug Class Employs Novel Mechanism for Migraine Treatment and Prevention
Recently approved drug class targeting calcitonin gene-related peptide (CGRP) – elevated in blood serum during migraine attacks
- New migraine drugs block effects of CGRP
- Specialized monoclonal antibodies cloned subclasses of immunoglobulin G (IgG)
- Designed to have low potential to interact with other drugs
- Metabolized differently with fewer adverse reactions
- Aimovig (erenumab-aooe), Ajovy (fremanezumab-vfrm), Emgality (galcanezumab-gnlm)
Image credit: FDA