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 responds to Kiacta "approvable" letter

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Neurochem's complete response is based on "complete follow-up" of all 183 Amyloid A amyloidosis patients in the Kiacta (eprodisate) Phase II/III trial, an option that FDA's August 2006 "approvable" letter had said could be "persuasive" in lieu of the one or more clinical trials to provide additional efficacy information and a safety update. The NDA for Kiacta (formerly Fibrillex), completed Feb. 13, has priority status for treatment of the orphan disorder (1Pharmaceutical Approvals Monthly May 2006, p. 3). Neurochem's follow-up analysis found a longer time to progress to dialysis/end-stage renal disease for Kiacta vs. placebo (p=.018) and non-statistically significant longer time to progress to a composite endpoint of dialysis/ESRD or death for Kiacta patients (p=.062)...

You may also be interested in...

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. 

Biotin And ‘Healthy Hair’: Federal Pre-emption Clips False Advertising Complaint In California

US Ninth Circuit affirms a district court’s summary judgment in favor of Target and manufacturer of Up & Up brand biotin supplement it sells. Indian manufacturer targeted in putative class-action in New York prompted FDA’s 2016 creation of import alert category for Ayurvedic supplements.





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