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

For Regeneron, Near-Term PCSK9 Filing, Eylea Growth Point To Rapidly Improving Prospects

This article was originally published in The Pink Sheet Daily

Executive Summary

Regeneron and partner Sanofi estimate there are more than 60 million addressable patients for LDL-lowering therapy in the U.S. and EU, including 22 million at very-high risk for a cardiovascular event. Meanwhile, a label addition for diabetic macular edema heightens the sales-growth prospects for Eylea.

You may also be interested in...



Sanofi/Regeneron’s PCSK9 Inhibitor Gets Reassuring CV Data – And A Priority Review Voucher

Alirocumab was associated with lower rate of major cardiovascular events compared to placebo in post-hoc, interim Phase III analysis – boosting chances for FDA approval in 2015. The firm is taking no chances on review period, purchasing a priority review voucher from BioMarin.

Preparing For Battle: PCSK9 Sponsors Stake Their Ground

The strong efficacy and sound safety data coming out of the Phase III programs presented at ACC have all eyes on the commercial opportunity for the PCSK9 inhibitor class. Ongoing outcomes trials and market impact of new cholesterol guidelines sparked discussion, and leading sponsors Amgen and Sanofi/Regeneron talked about the potential populations and differences in the devices and dosing of evolocumab and alirocumab.

US FDA’s New Drug Median Review Time Held Steady At Eight Months In 2021

The median review time for novel agents at CDER hasn’t changed in five years. Our infographic offers a look at the tortoises and hares (all of them winners because they got approved).

Topics

Related Companies

UsernamePublicRestriction

Register

PS077620

Ask The Analyst

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

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