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

Does Esperion's Plan For A Statin-Intolerant Claim Have A Shot?

Executive Summary

Esperion says it is working with FDA to forge a new regulatory path for its cholesterol drug ETC-1002 in statin-intolerant patients – a population the agency has been very cautious about in the past.

You may also be interested in...



Esperion Says FDA On Board With Filing Strategy For Bempedoic Acid

Unlike Amgen's FOURIER study of Repatha, which disappointed investors with a lower magnitude of benefit than expected, Esperion's outcomes trial of bempedoic acid will be done in patients with higher baseline LDL and will be much longer.

FDA’s Zetia/Vytorin Rejection Leaves Cholesterol Drug Sponsors In Limbo

FDA’s complete response letter for the cardiovascular risk reduction claim for Zetia/Vytorin was expected, but what will this mean for sponsors of drugs with other mechanisms, like PCSK9?

Amgen Racks Up Positive Phase III Data For Blincyto And Repatha

Company announces positive results from a confirmatory study of bispecific antibody Blincyto, on the heels of unveiling positive new data for PCSK9 inhibitor Repatha in statin-intolerant patients.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

PS057405

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