FDA News, July 5, 2015
Proteus Digital Health (redwood City, CA) has received an update to its FDA 510(k) clearance for its digital medicine platform, adding a new indication to the clearance. The system is now, to the company’s knowledge, the first technology to have an indication in its FDA clearance for measuring medication adherence. Reviews to be provided shortly
Storyline: This new digital. medicine technology could potentially address patient compliance issues and help ensure correct dosing.
Orkambi (Vertex Pharmaceuticals, Boston, MA)
First drug approved for cystic fibrosis directed at treating the cause of the disease in people who have two copies F508del mutation, which causes the production of an abnormal protein that disrupts how water and chloride are transported in the body
Orkambi (lumacaftor 200 mg/ivacaftor 125 mg) is now approved to treat cystic fibrosis (CF) in patients 12 years and older.
Expedited Development and FDA Review : Breakthrough Therapy designation, Priority Review, Orphan Drug Designation. Review to be posted shortly
Storyline: Expedited review and approval underscores FDA’s commitment to innovative treatments for serious rare diseases