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


Neurochem Fibrillex gets priority

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Neurochem's amyloid A amyloidosis treatment Fibrillex (eprodisate) has a priority review user fee date of August 13, the firm announces April 18. The rolling NDA for the orphan drug was completed Feb. 13 (1Pharmaceutical Approvals Monthly March 2006, In Brief). The application includes a Phase II/III trial that found 13.4% fewer patients worsened in the Fibrillex group compared to placebo. Neurochem estimates 17,000 people in the U.S. have AA amyloidosis; the disease usually progresses to end-stage renal disease. Fibrillex, a glycosaminoglycan mimetic, would be the first agent approved for the condition...

You may also be interested in...

Neurochem Fibrillex NDA

Neurochem completes rolling NDA submission for its orphan drug Fibrillex (eprodisate), the firm announces Feb. 13. The company is seeking an indication for amyloid A amyloidosis. "There is currently no treatment directed specifically at [the disease]," Neurochem says. The firm initiated the submission for the glycosaminoglycan mimetic in August 2005; the agent is part of FDA's continuous marketing application Pilot 1 and Pilot 2 programs (1Pharmaceutical Approvals Monthly September 2005, In Brief)...

Pink Sheet Podcast: Woodcock To Be Acting US FDA Chief, Key Staff Depart, Political Donations Shift

Pink Sheet reporters and editor discuss President-Elect Joe Biden’s decision to name the CDER director as acting FDA commissioner and other staffing changes, as well as changes to industry trade groups’ political donations.

Liquid Biopsy Company Delfi Diagnostics Raised $100M For New Class of Early Cancer Detection Test

Delfi Diagnostics will use the new funds to expand its team of cancer researchers and machine-learning experts to validate its novel approach for early cancer detection through multiple prospective clinical trials. 





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