Navigation Links
U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis Treatment
Date:9/5/2012

RARITAN, N.J., Sept. 5, 2012 /PRNewswire/ -- Janssen Research & Development, LLC (Janssen) announced today that the U.S. Food and Drug Administration (FDA) has granted Priority Review to the New Drug Application (NDA) for bedaquiline (TMC207) to treat pulmonary, multi-drug resistant tuberculosis (MDR-TB) in adults as part of combination therapy.

The FDA grants priority review to medicines that may offer major advances in care or provide a treatment option where no adequate therapy exists. Under the Prescription Drug User Fee Act (PDUFA), the FDA will aim to complete its review within six months of the NDA submission. The NDA was submitted June 29.

"There is a growing public health need for new treatment options for multi-drug resistant tuberculosis. If approved, bedaquiline would offer the first in a new class of anti-tuberculosis drugs for patients suffering from this serious and deadly disease," said Wim Parys, M.D., Head of the Infectious Diseases therapeutic area at Janssen. "We are working closely with the FDA and other regulatory agencies in high-burden countries to quickly bring bedaquiline to the patients who need it."  

The regulatory submission was supported by 24-week data from the Phase II clinical development program, which includes an open-label study and a controlled, randomized trial that evaluated the safety and efficacy of bedaquiline versus placebo in the treatment of patients with pulmonary MDR-TB in combination with a background regimen.

Bedaquiline is a diarylquinoline discovered by scientists at Janssen.

About Janssen Research & Development, LLC
At Janssen, we are dedicated to addressing and solving some of the most important unmet medical needs of our time in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Driven by our commitment to patients, we develop innovative products, services and healthcare solutions to help people throughout the world. Janssen Research & Development, LLC and Janssen Pharmaceuticals, Inc., are part of the Janssen Pharmaceutical Companies of Johnson & Johnson. Please visit http://www.janssenrnd.com for more information.

Media contacts:
Daniel De Schryver
+49 173 76 89 149
ddschryv@its.jnj.com

Pamela Van Houten
Phone: (609) 730-7902
Mobile: (908) 295-7367
pvanhou5@its.jnj.com

Investor contacts:
Stan Panasewicz
Phone: (732) 524-2524

Louise Mehrotra
Phone: (732) 524-6491

 


'/>"/>
SOURCE Janssen Research & Development, LLC
Copyright©2012 PR Newswire.
All rights reserved

Related medicine technology :

1. Nektar Announces that FDA Grants Fast Track Designation to NKTR-181, a New Oral Opioid Analgesic Molecule, for the Treatment of Moderate to Severe Chronic Pain
2. Community Foundation Announces $2.6 Million In Grants From Centinela Medical Funds
3. U.S. FDA Grants Priority Review to the New Drug Application for Bayers Regorafenib to Treat Patients with Metastatic Colorectal Cancer
4. European Commission Grants Orphan Medicinal Product Designation for Emmaus Medicals Sickle Cell Treatment
5. FDA Grants Orphan Drug Designation To GeNO LLC For Use Of Inhaled Nitric Oxide In Treatment Of Persistant Pulmonary Hypertension Of The Newborn (PPHN)
6. Rep. Fattah Announces More Than $10.7 Million in Grants for Neuroscience, Scientific and Medical Research in Philadelphia
7. HeartWare Stock Trading Halted Today; FDA Advisory Committee to Review HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation
8. Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
9. Frost & Sullivan Research Preview: Top 20 Telehealth Markets
10. Webcast Alert: Isis Pharmaceuticals Hosts Dr. Sotirios Tsimikas to Review KYNAMRO™ data Presented at the European Atherosclerosis Society 2012 Meeting
11. HemoShear Publishes Key Review on Human-Relevant Organotypic Systems
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:5/3/2016)... Utah , May 3, 2016  Forté Elements, LLC (Forté) is excited to ... nutritional products that address the nutritional needs of recovery for a variety of clinical ... products. Photo - http://photos.prnewswire.com/prnh/20160502/362548 Logo -  http://photos.prnewswire.com/prnh/20160502/362547LOGO ... ... ...
(Date:5/2/2016)... NEW YORK , May 2, 2016 Leading Economies ... Growth Ethiopia 10.2 Côte d,Ivoire 8.6 Uzbekistan 8 Ireland 7.8 India 7.3, ... TechSci Research, BRICS nations , which comprises of Brazil ... China and South Africa , registered the fastest ... economic slowdown in China , recession in Brazil ...
(Date:5/2/2016)... FRANCISCO , May 2, 2016 ... expected to reach USD 11.1 billion by 2024, ... View Research, Inc. Major drivers of the sonography ... therapeutic areas and government recommendations for periodic ultrasound ...      (Logo: http://photos.prnewswire.com/prnh/20150105/723757 ) ...
Breaking Medicine Technology:
(Date:5/5/2016)... ... May 05, 2016 , ... CURE Media Group , ... announced a new collaboration with Imerman Angels to expand outreach and emotional ... world. , “Imerman Angels provides an emotional lifeline to patients and families facing the ...
(Date:5/5/2016)... ... 2016 , ... With May flowers, summer is just around the corner. Summer means a lot ... school and the ability to play all day and night. Parents often lament the coming ... little tykes themselves. Summer also means trips to the beach, backyard cookouts, fireworks on the ...
(Date:5/5/2016)... NY (PRWEB) , ... May 05, 2016 , ... If ... or stretch marks on your skin, you may want to consider a treatment that ... MD, of Advanced Dermatology P.C. , Microneedling, also known as skin needling, ...
(Date:5/5/2016)... (PRWEB) , ... May 05, 2016 , ... ... support certifications, is pleased to announce its new referral program, giving participants incentive ... “Healthcare is a tight-knit community, and we know many professionals share resources with ...
(Date:5/5/2016)... Meadows, Ill. (PRWEB) , ... May 05, 2016 , ... ... 5 percent more than 2014 and up 27 percent since 2012. , The results ... trends – including another annual increase in skin cancer treatments and the growing popularity ...
Breaking Medicine News(10 mins):