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

Anidulafungin filing

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Vicuron (formerly Versicor) submits NDA for anidulafungin for the treatment of esophageal candidiasis, the firm announces April 28. The NDA also contains data on invasive candidemia/candidiasis and aspergillosis (1Pharmaceutical Approvals Monthly April 1, In Brief). The antifungal is the third filing in the echinocandin class, following Merck's approved Cancidas (caspofungin) and Fujisawa's "approvable" micafungi

You may also be interested in...



Vicuron To File Anidulafungin For Invasive Candidiasis Under Separate NDA

Vicuron’s revised regulatory strategy for anidulafungin involves filing a separate NDA for treatment of invasive candidiasis/candidemia and addressing other concerns through labeling discussions.

Vicuron Anidulafungin User Fee Extended; Dalbavancin NDA Coming 2H 2004

FDA’s request for additional bioavailability data on Vicuron’s anidulafungin has extended the user fee goal date to May 25.

Versicor preparing anidulafungin NDA

Versicor says it is on track to file its I.V. anidulafungin NDA by the end of April. Phase III esophageal candidiasis trial shows anidulafungin to be as effective as the standard of care, Pfizer's Diflucan. Anidulafungin yielded endoscopic success in 97.2% (242/249) patients compared to 98.8% (252/255) of patients on oral fluconazole, which "easily met" the statistical requirement for non-inferiority, Versicor says. However, anidulafungin had a statistically significantly higher relapse rate: endoscopic success at two weeks was 89.5% (205/229) for Diflucan and 64.4% (150/233) for anidulafungin. The NDA will also contain data from a Phase II trial in invasive candidemia/candidiasis and interim safety data from an ongoing Phase III study in aspergillosis. Anidulafungin could be the third entrant in the echinocandin class - Merck's Cancidas (caspofungin) was approved Jan. 26, 2001 and Fujisawa's micafungin was deemed "approvable" Jan. 29 (Pharmaceutical Approvals Monthly Feb. 1, In Brief

Topics

UsernamePublicRestriction

Register

PS002235

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