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


Enbrel Near Psoriasis User Fee Goal; Amgen Looking At "Step Down" Dosing

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Phase III psoriasis data for Amgen’s Enbrel show significant efficacy for a "step down" regimen combining initial loading doses of the tumor necrosis factor inhibitor with half-dose therapy over three months.

You may also be interested in...

Immunex Enbrel psoriatic arthritis approval

Immunex's TNF inhibitor Enbrel (etanercept) receives approval Jan. 16 for a new indication to reduce "signs and symptoms of active arthritis in patients with psoriatic arthritis." Enbrel can be used as monotherapy or together with methotrexate. Enbrel also gained clearance for multiple administrations from the same vial, a shelf life of 14 days compared to the previous six hours, and 24-month efficacy data on rheumatoid arthritis. Psoriatic arthritis patients will be enrolled in the Enbrel access program until manufacturing capacity is expanded. The company had estimated its Rhode Island plant could produce the agent by October, but Immunex's new owner Amgen projects a January 2003 start dat

FDA Priority Review Voucher Redemption Fee Set At $4.6 Million In FY 2011

Redeeming a priority review voucher obtained by developing a drug for a tropical disease will cost companies $6.1 million in fiscal 2011

September 2010 Approvals






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