Navigation Links
Simultaneous Applications Submitted to FDA and EMA for Siltuximab for the Treatment of Multicentric Castleman Disease, a Rare Blood Disorder
Date:9/3/2013

RARITAN, N.J., Sept. 3, 2013 /PRNewswire/ -- Janssen Research & Development, LLC ("Janssen") announced the simultaneous submissions of a Biologic License Application (BLA) to the United States Food and Drug Administration (U.S. FDA) and a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) for siltuximab for the treatment of patients with multicentric Castleman disease (MCD) who are HIV-negative and human herpes virus-8 (HHV-8)-negative.

MCD is a rare disorder in which lymphocytes, a certain type of white blood cells, are over-produced and lead to enlargement of lymph nodes.1, 2 This can cause a variety of symptoms and weaken the immune system, making it hard to fight infection. Infections in people with MCD can be very serious and may even be fatal.3 Currently, there are no approved treatments in the U.S. or European Union (EU) for this rare blood disorder.

"We're proud of our work on siltuximab. As a rare disease with a small patient population, MCD is an area of significant unmet need," said Peter F. Lebowitz, M.D., Ph.D., global oncology therapeutic area head, Janssen. "Siltuximab works by targeting interleukin-6 which appears to be the critical driver of this disease. By focusing on core biologic mechanisms, we now have the potential of helping patients with a condition that is challenging to treat."  

Siltuximab has been granted orphan drug status in MCD in the U.S. and EU. The siltuximab regulatory submissions include data from a randomized, multi-national, double-blind, placebo-controlled study (MCD2001) and data from two non-randomized supportive studies. The MCD2001 study assessed the efficacy and safety of siltuximab plus best supportive care (BSC) compared with placebo plus BSC in patients with MCD.4 In the study, 79 patients were randomly assigned in a 2:1 ratio to one of the two treatment
'/>"/>

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

Page: 1 2 3 4 5 6

Related medicine technology :

1. First Large-Scale Population-Based Study in the U.S. Shows Hologics 3D Mammography (Breast Tomosynthesis) Significantly Reduces Recall Rates While Simultaneously Improving Cancer Detection
2. Philips IMR offers new capabilities to simultaneously reduce CT Radiation and enhance image quality
3. Ventana Receives FDA Clearance for p53 (DO-7) Image Analysis and Digital Read Applications
4. Rubicon Genomics Launches ThruPLEX™ Family of Sample Preparation Products for Next Generation Sequencing Applications
5. Philips demonstrates innovations in nuclear medicine imaging with a comprehensive portfolio of NM applications for IntelliSpace Portal
6. Clinical Safety Data for ChromaDex®s Patented pTeroPure® (pterostilbene) Released at 6th World Congress on Polyphenols Applications in Paris
7. UltraTape announces Cleanroom Labels for Cryogenic Laboratory applications
8. New, Affordable Flow Cytometer Cell Sorter Expands Access to Wider Range of Life Science Applications
9. New Wireless Keyboard Rechargeable, Washable for Healthcare Applications
10. Frost & Sullivan: Label-Free Technology is a High Potential Market with Myriad Unexplored Applications
11. Radiotherapy Devices Market By Technology, Applications & Products (2011 - 2016)
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:12/22/2014)... TWi Biotechnology, Inc., today announced that ... TWi Biotechnology,s lead drug candidate, from The State ... for patent application numbered 201180018154.8.  This patent ... metabolite for treatment of type II diabetes.  The ... AC-201 for type II diabetes, and provides a ...
(Date:12/19/2014)... You,re visiting the dentist for what you ... or she says you need a root canal. Though ... have several questions and feel apprehensive about your upcoming ... nothing to worry about. The Pennsylvania Dental Association (PDA) ... anxiety the public may have surrounding this common procedure ...
(Date:12/19/2014)... N.C. , Dec. 19, 2014 ... optimize a product,s web presence to reflect the ... websites, in particular, must meet the needs of ... and culture. According to recent ... than half of the participating companies averaged more ...
Breaking Medicine Technology:TWi Biotechnology Receives Notice of Patent Allowance for Its Lead Drug Candidate AC-201 for the Indication of Type II Diabetes in China 2TWi Biotechnology Receives Notice of Patent Allowance for Its Lead Drug Candidate AC-201 for the Indication of Type II Diabetes in China 3Root Canals Have Become More Routine 2Building a Best-in-Class Pharma Global Brand Website 2
(Date:12/22/2014)... December 22, 2014 Physicians in China ... for the treatment of non-Hodgkin’s lymphoma (NHL), according to ... leading global healthcare consulting firm. MabThera is the only ... the most common form of NHL. , According to ... Barriers,” the incidence of NHL in China has been ...
(Date:12/22/2014)... 22, 2014 Explorys, the leader in ... its leadership team: Greg Yarrington as Vice President of ... Patrick Wells as Vice President of Solutions. These new ... new jobs in 2015 to support client demand for ... platform-as-a-service offerings, and growth of its partner network. ...
(Date:12/22/2014)... 2014 In recognition of Veteran’s Day, ... Hero Reward, a local organization that provides services to ... , Located on a couple hundred acres in the ... lodging, world class fishing, hunting, hiking, horseback riding, 4-wheeling, ... several years ago to support U.S. Service men and ...
(Date:12/22/2014)... New York NY (PRWEB) December 22, 2014 ... reports that a federal panel of judges has granted ... lawsuits in the U.S. District Court, Eastern District ... (JPML) issued an order on December 12 to transfer ... actions–pending in 22 districts to the Louisiana court for ...
(Date:12/22/2014)... 2014 Luxury Linen purveyor Peacock Alley ... Dallas to provide logistics and support for one of ... has a long history of giving back to the community ... this year's Toy Drive were Whataburger® and 99.5 The Wolf. ... the holidays. Providing gifts to children who would otherwise not ...
Breaking Medicine News(10 mins):Health News:Physicians in China See Most Significant Demand for MabThera Biosimilar 2Health News:Physicians in China See Most Significant Demand for MabThera Biosimilar 3Health News:Explorys Continues to Experience Rapid Growth, Adds Three Healthcare IT Executives to Its Leadership Team 2Health News:Explorys Continues to Experience Rapid Growth, Adds Three Healthcare IT Executives to Its Leadership Team 3Health News:Discount Labels Donates Portion of November Sales to Hero Reward Program 2Health News:Panel Orders Xarelto Lawsuits Consolidated Into Multi-District Litigation Reports Alonso Krangle LLP 2Health News:Panel Orders Xarelto Lawsuits Consolidated Into Multi-District Litigation Reports Alonso Krangle LLP 3Health News:Panel Orders Xarelto Lawsuits Consolidated Into Multi-District Litigation Reports Alonso Krangle LLP 4Health News:Peacock Alley and Community Partners of Dallas Fulfill an Estimated 12,000 Holiday Wishes for Deserving Children 2
... to treat bipolar disorder are more likely to get ... the //Systematic Treatment Enhancement Program for Bipolar Disorder (STEP-BD). ... National Institutes of Health’s (NIH) National Institute of Mental ... 2007 issue of the Archives of General Psychiatry. ...
... it off as just a part of growing older and ... ,“I was increasingly having painful menstrual periods, cramping, ... ,After running some tests, her doctor discovered that Ruma ... women, usually of childbearing age. In addition to painful menstrual ...
... Hindus and Sikhs to be allowed to hold open-air funerals, ... a charity //fighting for the cause being allowed to present ... the Anglo Asian Friendship Society, has been given permission to ... Justice Andrew Collins. ,The development follows a legal ...
... sun appears to impact more on the skin of males than ... exposed a breed of hairless mice to ultraviolet rays from a ... WebMD, The mice underwent eight- to 10-minute tanning sessions three times ... male and female mice skin cancer. ,"We found males ...
... This is one line of thought bra-burning women libbers ... book - Dressed To Kill (Avery Press, revised edition 2001) by ... had come out with claims that wearing a bra throughout ... , The authors claim to have discovered a possible trigger ...
... the chaos created by striking nurses, dentists have thrown in their ... medical card holders stand to lose access to free oral healthcare, ... voting for a withdrawal of support for the Dental Treatment Services ... scheme set up in 1994 to provide free oral ...
Cached Medicine News:Health News:Intensive Psychotherapy Effective in Treating Bipolar Disorder 2Health News:Intensive Psychotherapy Effective in Treating Bipolar Disorder 3Health News:Hope for Ending the Pain, Infertility of Endometriosis? 2Health News:Hope for Ending the Pain, Infertility of Endometriosis? 3Health News:Breast Cancer and Bra Wearing: Possibly Linked 2
... VenaCure Laser Vein Treatment. It is estimated ... worldwide have varicose veins. In the United States, ... of 60 suffer from painful and unsightly venous ... the capabilities of vascular therapy for the treatment ...
ELVeS is a new minimally-invasive laser treatment for patients with superficial vein reflux of the greater saphenous vein. The ELVeS laser treatment offers your patients an effective out-patient alt...
... technology provides practitioners with the ability to treat ... permanent hair reduction on all skin types and ... the practitioner to instantly switch to a 3, ... a simple twist of the handpiece dial while ...
... people are diagnosed with varicose veins every ... never seek treament and are apprehensive of ... them an effective alternative to conventional therapies., ... hook phlebectomy), is considered a laborious procedure ...
Medicine Products: