Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

Empagliflozin Likely Needs Another Trial After Rebuke By US FDA Panel

Executive Summary

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.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS141197

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel