Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

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

Omacor Data Inadequate To Support Use With Statins, FDA Says

This article was originally published in The Pink Sheet Daily

Executive Summary

Added benefit was seen with simvastatin, but reviewers noted that statin doses in studies were too low. Labeling makes no mention of concomitant use with statins or other lipid-altering therapies. Reliant is pursuing additional indications for the omega-3 fatty acids product, including possible use with statins or its fenofibrate Antara.

You may also be interested in...



Reliant's Antara Launch Set For First Quarter, Omacor Will Be Later

The cholesterol products have the potential to transform the company by generating annual sales of $150 mil. each, CEO Ernest Mario says. Reliant is considering possible combinations for Omacor; options include Antara or a statin.

Madrigal’s FDA Approval In MASH Ends Years Of Industry Frustration

As the first approved MASH (formerly NASH) therapy, nearly four years after initially anticipated, Madrigal gets the opportunity to establish a MASH marketplace with Rezdiffra (resmetirom).

No More NASHing Of Teeth: Madrigal’s Resmetirom Approval Ends Years Of Industry Frustration

US FDA clears first MASH (formerly NASH) therapy, nearly four years after one had been initially anticipated. With the accelerated approval path established, Madrigal gets the opportunity to create a marketplace with Rezdiffra (resmetirom), and candidates in the pipeline get a clear target.

Topics

Latest Headlines
See All
UsernamePublicRestriction

Register

PS061645

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. 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