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


La Jolla reactivates Phase III Riquent trial

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

La Jolla has reactivated enrollment in a Phase III trial of Riquent (abetimus sodium) in lupus renal disease under a special protocol assessment. The trial is being conducted at FDA's request based on clinical deficiencies relating to the firm's previous Phase II and Phase III trials cited in an October 2004 "approvable" letter (1Pharmaceutical Approvals Monthly November 2004, p. 13). FDA recommended another study to distinguish Riquent from placebo through an endpoint such as time to renal flare. La Jolla plans to enroll 600 patients by the second half of 2007 and has expanded the trial to include Europe and Mexico...

You may also be interested in...

La Jolla’s Long Road To Riquent Approval Takes Another Turn

La Jolla Pharmaceutical is modifying an ongoing Phase III trial evaluating its systemic lupus erythematosus candidate Riquent (abetimus) in a manner that will push back the study findings beyond the latest anticipated timeline

Riquent "Approvable" For Lupus; FDA Says Ongoing Study Could Be Enough

La Jolla Pharmaceuticals hopes running a parallel study alongside the ongoing confirmatory trial for its lupus agent Riquent will satisfy the requirements set out in FDA’s Oct. 14 "approvable" letter.

Cybersecurity: Guidance Docs To Come, But Legacy Devices Still A Challenge

Increasing savvy around cybersecurity issues is driving regulators and trade groups to update their approach to the area, speakers from the US FDA and the American Medical Association said at this week’s FDA/CMS Summit.





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