Scrip 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

Emerging Markets Focused J&J’s Sirturo Approval Tied To Expansive Post-Marketing Study Program

This article was originally published in PharmAsia News

Executive Summary

The first drug approved for multi-drug resistant tuberculosis, Sirturo obtained accelerated approval based on data from two Phase II studies, but has a troubling safety database, including 10 deaths in the treatment arm of its Phase II program.

You may also be interested in...



Janssen’s Sirturo Needs Minor Tweaks To Confirmatory Trial, FDA Panel Says

Gathering more data to assuage concerns about possibly lower efficacy in black patients will be key to converting the accelerated approval to full approval for the tuberculosis drug, FDA’s Anti-Infective Drugs Advisory Committee concludes.

J&J’s Sirturo Gets Panel Endorsement For Accelerated OK, Even As FDA Broaches Full Approval

FDA’s Anti-Infective Drugs Advisory Committee was fully satisfied with “sputum culture conversion” as a surrogate endpoint for accelerated approval, but turned back a last-minute question from FDA on traditional full approval for the tuberculosis drug bedaquiline.

Janssen’s Sirturo: TB Milestone Awaits After Advisory Committee Hurdle

Important safety questions remain for what could be the first new tuberculosis drug in 40 years, and there was a lack of efficacy in the key subgroup of black patients.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

SC082604

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

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