In Vivo 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

Nitromed's BiDil Could Be First Drug Approved Specifically For African Americans

This article was originally published in The Pink Sheet Daily

Executive Summary

Company plans NDA resubmission by year-end with results from African American Heart Failure Trial in response to 2001 "approvable" letter for treatment of heart failure in African American patients. A-HeFT data show 43% survival improvement with BiDil vs. placebo.

You may also be interested in...



Nitromed’s BiDil Should Not Be Second-Line Therapy, FDA Says

BiDil should be indicated for first-line treatment of chronic heart failure in African American patients, FDA says in briefing material for the Cardiovascular & Renal Drugs Advisory Committee’s June 16 review of the Nitromed product. Nitromed had requested a second-line indication. BiDil would be the first drug specifically indicated for African Americans

Nitromed’s BiDil Should Not Be Second-Line Therapy, FDA Says

BiDil should be indicated for first-line treatment of chronic heart failure in African American patients, FDA says in briefing material for the Cardiovascular & Renal Drugs Advisory Committee’s June 16 review of the Nitromed product. Nitromed had requested a second-line indication. BiDil would be the first drug specifically indicated for African Americans

NitroMed BiDil One Year Ahead Of Schedule Following Positive Study Results

The firm is planning for a first quarter 2005 launch after a trial in African American heart failure patients is halted early due to significant survival benefit. Initial positioning will be as an add-on to standard heart failure therapies. NitroMed sees a market opportunity of $1 bil.

Related Content

Topics

UsernamePublicRestriction

Register

PS058131

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

Cancel