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

Special protocol assessment for HGS/GSK LymphoStat-B

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

FDA grants an SPA for Phase III trials of LymphoStat-B (belimumab) in active systemic lupus erythematosus, Human Genome Sciences announces Oct. 26. The pivotal program, expected to start by year-end, will include two superiority trials, the 52-week BLISS-52 and 76-week BLISS-76 studies, each to enroll 810 patients with serologically active SLE. The SPA accepts a combined patient response rate endpoint that "emerged directly" from GSK and HGS' analysis of a Phase II study that failed to show clinical benefit at week 24 (1Pharmaceutical Approvals Monthly August 2006, p. 32)...

You may also be interested in...



Genentech Rituxan Failed Lupus Trial Also Takes Down Ocrelizumab For SLE

Genentech is abandoning development of both its anti-CD20 monoclonal antibodies for systemic lupus erythematosus after the failure of Rituxan (rituximab) in the Phase II/III EXPLORER trial cast doubt on the validity of targeting the CD20 antigen on B-cells as an approach to SLE.

HGS LymphoStat-B to begin Phase III in Q4

Human Genome Sciences will begin a Phase III trial of LymphoStat-B (belimumab) in patients with active systemic lupus erythematosus in the fourth quarter of 2006, the company announces Aug. 9. HGS expects a $24 mil. milestone payment from development partner GlaxoSmithKline in the third quarter. HGS collaborated with GSK to design the Phase III study, which has an endpoint that combines response rate and elements of the SELENA SLEDAI and BILAG disease activity indices, as well as the Physician's Global Assessment index. A Phase II study failed to show a clinical benefit at week 24, but HGS previously indicated its belief that the Phase II data are strong enough to move into Phase III studies (1Pharmaceutical Approvals Monthly July 2006, p. 16)...

FDA Talks Tough On Complete Response Extensions

The FDA has published fresh guidance taking a tougher stance on sponsor reasons for needing more time to respond to complete response letters.

Topics

UsernamePublicRestriction

Register

LL1134044

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