Empagliflozin Likely Needs Another Trial After Rebuke By US FDA Panel
Expanded indication for type 1 diabetes seems out of reach for the moment, but if Boehringer conducts a larger and lengthier trial, it could eventually persuade members of the Endocrinologic and Metabolic Drugs Advisory Committee who voted 14-2 against supplemental approval of empagliflozin for the proposed 2.5mg dose.
You may also be interested in...
Keeping Track: US FDA Okays BMS’ Zeposia In MS, Nixes Lilly/BI’s Empagliflozin For Type 1 Diabetes
The latest drug development news and highlights from the Pink Sheet US FDA Performance Tracker.
March Madness: Upcoming US FDA Decision Dates To Watch
A dozen applications for new drugs and significant new indications are on the US FDA’s calendar of goal dates, including breakthrough-designated applications from Bristol-Myers Squibb and Boehringer Ingelheim.
As Sanofi Exits Diabetes R&D, Meaning Of ‘Diabetes R&D’ Blurs
Cardiovascular outcome trials are driving development in blockbuster SGLT-2 inhibitor and GLP-1 agonist classes to look beyond HbA1c levels to focus on cardiovascular and renal protective effects.