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 $10.7 Million in Grants for Neuroscience, Scientific and Medical Research in Philadelphia
7. HeartWare Stock Trading Halted Today; FDA Advisory Committee to Review HeartWare® Ventricular Assist System as a Bridge to Heart Transplantation
8. Onyx Pharmaceuticals Announces FDA Advisory Committee to Review Carfilzomib for the Treatment of Patients with Relapsed and Refractory Multiple Myeloma
9. Frost & Sullivan Research Preview: Top 20 Telehealth Markets
10. Webcast Alert: Isis Pharmaceuticals Hosts Dr. Sotirios Tsimikas to Review KYNAMRO™ data Presented at the European Atherosclerosis Society 2012 Meeting
11. HemoShear Publishes Key Review on Human-Relevant Organotypic Systems
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:4/20/2017)... , April 20, 2017 Research and ... Pharmaceutical Contract Manufacturing Services Market Analysis By Service (Manufacturing, Research), ... Forecasts, 2014 - 2025" report to their offering. ... The Latin American pharmaceutical ... billion by 2025 Low drug registration cost in ...
(Date:4/19/2017)... The Mobile X-Ray product segment is the most ... the forecast period Mobile X-Ray segment is the ... X-Ray devices market, which is estimated to be valued at ... CAGR of 7% over the forecast period. Mobile X-Ray segment ... US$ 100 Mn in 2017 over 2016. The segment,s revenue ...
(Date:4/19/2017)... Global Prostate Cancer Therapeutics Market: Overview ... cancer therapeutics market analyzes the current and future ... prostate cancer, launch of promising emerging therapies, as ... drugs & therapeutic biological products, and high growth ... side effects are some of the drivers expected ...
Breaking Medicine Technology:
(Date:4/28/2017)... ... April 28, 2017 , ... Datta ... M.D. has joined the revolutionary endoscopic practice under Dr. Datta. Patel is a ... Pain Medicine. The patented, revolutionary eDiscSculpt Technique created and used by Datta Endoscopic ...
(Date:4/28/2017)... ... April 28, 2017 , ... People are starting to ... “Wearing a hearing aid doesn’t have the stigma it had when great-grandpa wore his ... of Greater Boston, in a NALA North American Speaker Series (NASS) segment. ...
(Date:4/28/2017)... ... April 28, 2017 , ... ... the Brooke Grove Foundation implement a Microsoft Dynamics GP solution that integrates to ... ERP expert that specializes in long-term care, Brooke Grove now has the capability ...
(Date:4/28/2017)... ... 2017 , ... Christie Medical Holdings, Inc. , with its market-leading ... Medical Inc. , a leader in infusion therapy and pain management. , Intravenous ... percent of hospital patients receiving a peripheral IV catheter as part of their treatment ...
(Date:4/27/2017)... ... April 27, 2017 , ... The American Brain Foundation ... Leadership in Neurology Award (PLINA). The couple joins a prestigious list of past ... Walter Mondale, actor Michael J. Fox and former U.S. Attorney General Janet Reno. ...
Breaking Medicine News(10 mins):