Navigation Links
Bayer's Investigational Drug Riociguat Granted FDA Orphan Drug Designation for Treatment of Pulmonary Arterial Hypertension and Chronic Thromboembolic Pulmonary Hypertension
Date:9/25/2013

WHIPPANY, N.J., Sept. 25, 2013 /PRNewswire/ -- Bayer HealthCare today announced that the U.S. Food and Drug Administration's (FDA) Office of Orphan Products Development has granted two separate orphan drug designations for its investigational, oral medication riociguat, proposed trade name Adempas®, for the treatment of pulmonary arterial hypertension (PAH) and chronic thromboembolic pulmonary hypertension (CTEPH). The Orphan Drug Designation program provides orphan status to drugs and biologics that are defined as those intended for the safe and effective treatment, diagnosis or prevention of rare diseases and disorders that affect fewer than 200,000 people in the U.S., or that affect more than 200,000 persons but are not expected to recover the costs of developing and marketing a treatment drug.

Bayer submitted a New Drug Application (NDA) for riociguat in February 2013 for two indications: (i) the treatment of PAH (WHO Group 1) to improve exercise capacity, improve WHO functional class and delay clinical worsening; and (ii) the treatment of persistent/recurrent CTEPH (WHO Group 4) after surgical treatment or inoperable CTEPH to improve exercise capacity and WHO functional class.

PAH and CTEPH are both life-threatening forms of pulmonary hypertension that cause significantly increased pressure in the pulmonary arteries. Riociguat is an investigational, oral medication for the treatment of adult patients with PAH or persistent/recurrent CTEPH after surgical treatment or inoperable CTEPH.  If approved by the FDA, it would create a new class of drugs available in the U.S.  Pulmonary hypertension is associated with endothelial dysfunction, impaired synthesis of nitric oxide (NO) and insufficient stimulation of soluble guanylate cyclase (sGC). Riociguat stimulates sGC independent of NO and increases the sensitivity of sGC to NO.

About Pulmonary Arterial Hypertension (PAH)

In PAH, a
'/>"/>

SOURCE Bayer HealthCare Pharmaceuticals
Copyright©2012 PR Newswire.
All rights reserved

Page: 1 2 3

Related medicine technology :

1. Diabetes Alliance to Feature 17 Presentations for Linagliptin and Investigational Compound Empagliflozin^ During the 49th Annual Meeting of the European Association for the Study of Diabetes (EASD)
2. Boehringer Ingelheims investigational volasertib receives FDA Breakthrough Therapy designation
3. Data for Investigational Tiotropium Show Improved Lung Function and Sustained Bronchodilation in Patients with Moderate Asthma Severity
4. Takedas New Investigational Drug Vedolizumab is Granted Priority Review Status by U.S. Food and Drug Administration for Ulcerative Colitis
5. Data Published in the New England Journal of Medicine for Vedolizumab, an Investigational New Drug from Takeda for Moderately to Severely Active Ulcerative Colitis and Crohns Disease
6. FDA Grants Orphan Drug Status To Eisais Investigational Compound (E7777) For Cutaneous T-Cell Lymphoma
7. New Data for Abbotts Investigational High Sensitive Troponin Test Shows It May Help Doctors Predict Heart Attack Risk
8. Grifols Implements Its First Automated Inventory Management Carousel System for Investigational Pharmacies at Emory University
9. Signum Dermalogix Investigational New Drug (IND) Application Cleared by FDA: SIG990 a Potential Treatment for Rosacea
10. Sanofi Announces Positive Phase 3 Results for Investigational New Insulin U300
11. Phase III study finds investigational agent empagliflozin significantly reduced blood glucose in adults with type 2 diabetes and impaired kidney function
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:7/24/2014)... Mass. , July 24, 2014   Royal ... today announced that it has received 510(k) clearance from ... innovative ultra mobile ultrasound system, VISIQ, in the U.S. ... to combine the benefits of greater mobility, performance and ... access to quality diagnostic scans for more OB patients. ...
(Date:7/24/2014)... 24, 2014 Second Quarter and ... and Chief Executive Officer effective September 2, 2014 ... million , BioGlue ® revenues grew 14 ... revenues grew 22 percent year-over-year to $1.1 million ... percent year-over-year to $1.7 million , Tissue processing ...
(Date:7/24/2014)... July 24, 2014  Bayer HealthCare today announced ... evaluated a 15% foam formulation of its compound ... inflammatory papules and pustules of rosacea. An AzA ... complement the currently available AzA gel formulation. Papulopustular ... (papules and pustules) as well as erythema (redness) ...
Breaking Medicine Technology:Philips receives FDA 510(k) clearance for its innovative ultra mobile VISIQ ultrasound system 2Philips receives FDA 510(k) clearance for its innovative ultra mobile VISIQ ultrasound system 3CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 2CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 3CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 4CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 5CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 6CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 7CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 8CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 9CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 10CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 11CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 12CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 13CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 14CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 15CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 16CryoLife Second Quarter 2014 Revenues Increase 3 Percent to a Record $34.7 Million 17Phase III Investigational Trial of Azelaic Acid 15% Foam Meets Both Co-Primary Endpoints in Subjects with Papulopustular Rosacea 2Phase III Investigational Trial of Azelaic Acid 15% Foam Meets Both Co-Primary Endpoints in Subjects with Papulopustular Rosacea 3
... nContact, Inc., the leading innovator in epicardial ablation ... websites, www.ncontactinc.eu and www.ncontactinc.com . The ... of nContact,s technology and the market for treating cardiac ... "The new websites are excellent educational references that highlight ...
... 2011 Galleon Pharmaceuticals, a leader in the pharmaceutical ... of directors has elected Thomas J. Dietz, Ph.D., as ... of Waypoint Holdings, LLC, a diversified financial-holdings and services ... co-CEO and then CEO and a director of Pacific ...
Cached Medicine Technology:nContact, Inc. Launches New Corporate Websites 2Thomas Dietz, Ph.D., Elected Chairman of Galleon Pharmaceuticals 2
(Date:7/24/2014)... can be reduced by enabling patients to see the ... This is just one of several recommendations made in ... University of Bristol. , Called ,Primary care factors and ... report has been compiled by researchers from the University,s ... from studies around the world. They found that patients ...
(Date:7/24/2014)... American air and missile defense radar market has been estimated ... a CAGR of 9.64% to reach $340 million by 2020. ... drug trafficking. Brazil is the only market in the region ... radar market. This is followed by Argentina and Chile, which ... in terms of costal surveillance and other air defense radar. ...
(Date:7/24/2014)... July 24, 2014 Dr. Peter Oettgen, ... Deaconess Medical Center in Boston, is the new Deputy ... Oettgen brings his considerable experience in the field to ... . , Dr. Oettgen received his medical degree ... completed his residency at Tufts New England Medical Center. ...
(Date:7/24/2014)... July 24, 2014 Boston Children’s Museum ... Sky, funded by NASA and created through a partnership ... The exhibit is an immersive and inspiring traveling exhibit ... 10, in early investigations of astronomical science. It ... includes a tour of the universe, reveals secrets of ...
(Date:7/24/2014)... protein p53 refers to cancer biology, and the functions ... described in detail. Furthermore, also in cancer biology, it ... tumour cells in order to block their metabolism and ... innovative research on p53 attempts to unveil its functions ... healthy cells. Recent studies with cell cultures have demonstrated ...
Breaking Medicine News(10 mins):Health News:Seeing the same GP at every visit will reduce emergency department attendance 2Health News:South America Air and Missile Defense Radar Market is Expected to Reach $340 Million in 2020 - New Report by MicroMarket Monitor 2Health News:South America Air and Missile Defense Radar Market is Expected to Reach $340 Million in 2020 - New Report by MicroMarket Monitor 3Health News:South America Air and Missile Defense Radar Market is Expected to Reach $340 Million in 2020 - New Report by MicroMarket Monitor 4Health News:South America Air and Missile Defense Radar Market is Expected to Reach $340 Million in 2020 - New Report by MicroMarket Monitor 5Health News:DynaMed™ Names Peter Oettgen, MD as Deputy Editor of Cardiology 2Health News:DynaMed™ Names Peter Oettgen, MD as Deputy Editor of Cardiology 3Health News:My Sky Exhibit Opens at Boston Children’s Museum 2Health News:My Sky Exhibit Opens at Boston Children’s Museum 3Health News:My Sky Exhibit Opens at Boston Children’s Museum 4Health News:My Sky Exhibit Opens at Boston Children’s Museum 5Health News:Identified a key molecule in flies that adjusts energy use under starvation conditions 2
... to develop malignancies after radiation treatments , , MONDAY, Feb. ... the success of childhood cancer treatments, researchers report that ... Hodgkin,s disease were almost 40 times more likely to ... cure most patients now who have Hodgkin,s disease. Back ...
... more headaches, new study suggests , , MONDAY, Feb. 16 (HealthDay ... naps to sleep it off, but they run the risk ... perpetuating the cycle of headaches, a new study shows. , ... tried to treat their headaches, and they rated it a ...
... members step down to become observers -SAN DIEGO, ... of wireless, handheld barcode point-of-care (BPOC) solutions ... Laub, Chief Executive Officer of Policy Studies ... Board of Directors. (Logo: http://www.newscom.com/cgi-bin/prnh/20090121/LA60632LOGO )" ...
... AUSTIN, Texas, Feb. 16 In 2007, Bedrest Fitness ... program. The first of its kind, Bedrest Fitness ... or restricted activity can perform to help maintain muscle strength and tone. ... Ejercicios Para ...
... MYL ) announced today that it will host ... 2009, at 5:00 p.m. ET to review the company,s financial ... Mylan will release its financial results on February 19 ... 19 call is 888-287-5536 or 719-325-2126 for international callers. ...
... often deserving 2009 SSI Disability cases will not ... of mistakes made on the disability application. The ... disabled consumers to take additional time ensuring they ... and submitted the proper supporting medical evidence. This ...
Cached Medicine News:Health News:Hodgkin's Survivors Prone to Breast Cancer Later 2Health News:Hodgkin's Survivors Prone to Breast Cancer Later 3Health News:Using Sleep to Manage Headaches May Cause Insomnia 2Health News:Using Sleep to Manage Headaches May Cause Insomnia 3Health News:Margaret Laub Appointed to IntelliDOT Board of Directors 2Health News:Margaret Laub Appointed to IntelliDOT Board of Directors 3Health News:Margaret Laub Appointed to IntelliDOT Board of Directors 4Health News:Spanish Exercise DVD Helps Latinas Reduce Risk of Preterm Labor 2Health News:SSI Disability Application Tips for 2009 2Health News:SSI Disability Application Tips for 2009 3Health News:SSI Disability Application Tips for 2009 4Health News:SSI Disability Application Tips for 2009 5
... evaluation of pancreatic -cell function is not only ... of the natural history of diabetes mellitus, but ... guide to the correct choice of treatment. Peripheral ... function because of the large and variable uptake ...
... for the control of glucose metabolism. It ... of Langerhans as the precursor, proinsulin, which is ... are secreted in equimolar amounts into the portal ... of two polypeptide chains, the A-chain and B-chain ...
ENA Screen EIA Auto-Immune Markers 012-MDKES1 Extractable Nuclear Antigens...
Anti-PR3 EIA Auto-Immune Markers 013-PR3-48 Proteinase...
Medicine Products: