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:8/3/2015)... Pa. , Aug. 3, 2015 VWR ... laboratory products, services and solutions, announces the redesign of its ... customers. When visiting the new site, guests ... with bold colors and vivid images.  Each country site now ... an A to Z product menu; and , the ...
(Date:8/3/2015)... SPRINGS, Florida , August 3, 2015 /PRNewswire/ ... HOLD -- FN Media Group LLC, PIV757417 The ... Focus on Developing Orphan Drug Products & Treatments ... now OFF HOLD. Distribution time: 3 Aug 2015 ... agreements between biotech companies, military surgical research and ...
(Date:8/3/2015)... 2015  Charleston Laboratories, Inc., an emerging specialty ... development program with a Phase 1 study on ... CL-H1T contains fast-dissolving promethazine and sumatriptan.  This novel ... for migraine headache pain and migraine-induced nausea and ... migraine headaches also suffer from nausea and vomiting," ...
Breaking Medicine Technology:VWR's New Website Redesign Provides Improved Functionality for Customers 2/OFF HOLD OFF HOLD OFF HOLD -- FN Media Group LLC/ 2/OFF HOLD OFF HOLD OFF HOLD -- FN Media Group LLC/ 3/OFF HOLD OFF HOLD OFF HOLD -- FN Media Group LLC/ 4/OFF HOLD OFF HOLD OFF HOLD -- FN Media Group LLC/ 5/OFF HOLD OFF HOLD OFF HOLD -- FN Media Group LLC/ 6Charleston Laboratories, Inc. Initiates Patient Enrollment in a Phase 1 Study of Charleston's Second Product, CL-H1T 2
... , AUSTIN, Texas, Dec. 9 Ascension ... recent hiring of two veteran executives, L. Robert Johnston, Jr. ... Vice President of Marketing. "These individuals bring a wealth of ... future growth of Ascension," said Guy Mayer, CEO. "As members ...
... Dec. 9 BioCryst Pharmaceuticals, Inc. (Nasdaq: BCRX ) ... to the Company,s Board of Directors. Dr. Sanders brings ... physician and professor of medicine. , "We are ... said Zola P. Horovitz, Ph.D., Chairman of the Board of ...
Cached Medicine Technology:Ascension Orthopedics Hires Key Senior Executives 2BioCryst Pharmaceuticals Elects Charles A. Sanders to its Board of Directors 2BioCryst Pharmaceuticals Elects Charles A. Sanders to its Board of Directors 3BioCryst Pharmaceuticals Elects Charles A. Sanders to its Board of Directors 4
(Date:8/3/2015)... ... 03, 2015 , ... Since 1978, the number of black males applying to ... released today by the AAMC (Association of American Medical Colleges). , Despite an ... decades, the number of black male applicants to medical school dropped to 1,337 in ...
(Date:8/3/2015)... Angeles, CA (PRWEB) , ... August 03, 2015 , ... According to an opinion ... calories out of person’s diet leads to one pound of weight loss may not be ... caloric reduction that translates to one pound of fat varies – based both on the ...
(Date:8/3/2015)... ... August 03, 2015 , ... BESLER Consulting today announced the ... , The MarketingProfs Bright Bulb B2B Awards celebrate the best marketing, communications, and ... launch of their Readmissions Analytics product was selected as one of four finalists ...
(Date:8/3/2015)... ... August 03, 2015 , ... A ... while an overwhelming number of Hispanics believe people can positively affect their diabetes, ... of participants queried said making diet changes was important. Far fewer participants mentioned ...
(Date:8/3/2015)... ... August 03, 2015 , ... ... and amputation , AUGUST 3, 2015 – Since winning a South by Southwest® ... Not Impossible – an organization whose mission is to develop technology for the ...
Breaking Medicine News(10 mins):Health News:New Publication Focuses on the Decline of Black Males in Medicine 2Health News:New Publication Focuses on the Decline of Black Males in Medicine 3Health News:New Publication Focuses on the Decline of Black Males in Medicine 4Health News:Article Dispelling Weight Loss Myth Correctly Emphasizes the Complicated and Difficult Nature of Weight Loss, Says Dr. Michael Feiz 2Health News:Hispanics More Likely to Struggle with Misinformation About Diabetes 2Health News:Hispanics More Likely to Struggle with Misinformation About Diabetes 3Health News:Hispanics More Likely to Struggle with Misinformation About Diabetes 4Health News:Not Impossible Earns Top Awards for Technologies Benefiting Humanity 2Health News:Not Impossible Earns Top Awards for Technologies Benefiting Humanity 3Health News:Not Impossible Earns Top Awards for Technologies Benefiting Humanity 4
... Genetic factors may be at play when it comes ... and vulnerability for depression// , according to a new ... the October issue of the journal Archives of General ... genetic analyses that showed that neuroticism is a strong ...
... Ooteman a Dutch researcher has stumbled upon some very ... of understanding// the biological and genetic characteristics of alcoholics, ... curb the irresistible urge to drink. ,The urge ... like Naltrexone and Acamprosate. The investigations done by the ...
... focus on U.S. soldiers seriously wounded or injured during ... //severity may predict the risk for posttraumatic stress disorder ... 2006 issue of The American Journal of Psychiatry, the ... study written by Thomas A. Grieger, M.D., and colleagues ...
... Manchester Been honored with a prized award for research ... suffer from chronic or acute back pain worldwide. ... Student annually at the Science, Engineering and Technology Student ... Ambury. ,She examined how special ‘Braces’ or ...
... immigration detention centers has been accused of providing inadequate ... the prison watchdog.// ,Chief Inspector of Prisons ... Wood Immigration Removal Centre in Bedfordshire following concerns raised ... Uganda. ,Although Owers praised the work of ...
... research reported that ragweed or hay fever symptoms could be ... vaccine developed at Johns Hopkins in Baltimore. ,Dr. ... and Allergy Center at the Johns Hopkins University School of ... fall ragweed seasons in Baltimore. ,The study was ...
Cached Medicine News:Health News:Link Between Neuroticism and Depression May be Genetic 2Health News:DNA vaccine for ragweed allergies 2
... Designed for High Throughput Screening (HTS), ... assays into HTS by sharing all ... of Analyst AD, fluorescence intensity, fluorescence ... Optimized for seamless integration into robotic ...
... for cell-based assays, the NOVOstar provides both ... the flexibility of an on-board reagent pipet. ... to plate or from three reagent stations ... unit has two injectors that can accurately ...
... High sensitivity and ... for eight different radiometric ... first system with true ... radiometric assays, by exploiting ...
This a new dedicated VICTOR2 model for fluorescence, fluorescence polarization and luminescence measurement with stacker and robotic loading....
Medicine Products: