Navigation Links
U.S. FDA Grants Priority Review to Bedaquiline (TMC207) for Multi-Drug Resistant Tuberculosis Treatment

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 for more information.

Media contacts:
Daniel De Schryver
+49 173 76 89 149

Pamela Van Houten
Phone: (609) 730-7902
Mobile: (908) 295-7367

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:
(Date:11/26/2015)... , November 26, 2015 ... addition of the "2016 Future Horizons ... of Abuse Testing Market: Supplier Shares, Country ... report to their offering. --> ... the "2016 Future Horizons and Growth ...
(Date:11/26/2015)... ) has announced ... High Viscosity Drugs" report to their offering. ... addition of the "Self Administration of High ... --> Research and Markets ( ) ... Administration of High Viscosity Drugs" report to ...
(Date:11/25/2015)... 2015  The total global healthcare industry is expected to ... Latin America has the highest projected growth ... Japan ), is second with growth projected at ... increased healthcare expenditure. In 2013-2014, total government funded healthcare was ... 2008-2009 to 41.2% in 2013-2014. In real terms, out of ...
Breaking Medicine Technology:
(Date:11/27/2015)... ... November 27, 2015 , ... ... 27th edition of USA Today in Atlanta, Dallas, New York, Minneapolis, South Florida, ... The digital component is distributed nationally, through a vast social media strategy and ...
(Date:11/27/2015)... ... November 27, 2015 , ... Intellitec Solutions announced today ... Group (MSDSLUG). Recognized as Microsoft’s official group for end users of Dynamics SL ... users, partners, industry experts and representatives. Intellitec Solutions’ membership status demonstrates their ongoing ...
(Date:11/27/2015)... ... 2015 , ... CBD College is proud to announce that on ... accreditation to its Diagnostic Medical Sonography program. CBD College is honored to join this ... colleges and universities in the state of California make the cut. CBD College is ...
(Date:11/27/2015)... ... November 27, 2015 , ... Indosoft Inc., developer ... incorporation of Asterisk 11 LTS (Long Term Support) into its Q-Suite 5.10 product ... Q-Suite 5.10 up-to-date with a version of Asterisk that will receive not only ...
(Date:11/26/2015)... ... November 26, 2015 , ... Somu Sivaramakrishnan announced today that ... Somu now offers travelers, value and care based Travel Services, including exclusive pricing ... well as, cabin upgrades and special amenities such as, shore excursions, discounted fares, ...
Breaking Medicine News(10 mins):