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:11/28/2014)... Nov. 28, 2014 /CNW Telbec/ - Ergoresearch Ltd (TSXV: ERG) ... under the « Équilibre, orthèses et biomécanique» banner  – ... 30, 2014. All dollar amounts in the present release are ... quarter of fiscal year 2015 ended this past September 30, ... compared to revenues of $ 4 227 942 for the quarter ...
(Date:11/28/2014)... 2014 According to MedlinePlus, back pain will affect ... lifetime. For many, these pains are only temporary, for others, ... a variety of factors. For those whose chronic pain is ... option. While there are a variety of surgical options out ... M. Rezaian , M.D., Ph.D., F.R.C.S., F.I.C.S. has several advantages ...
(Date:11/28/2014)... 2014  Valeant Pharmaceuticals International, Inc. (NYSE: ... its wholly owned subsidiary, Valeant Pharmaceuticals International, will ... outstanding 6.875% Senior Notes due 2018, CUSIP Nos. ... 29, 2014 and has mailed an irrevocable notice ... approximately US$500 million aggregate principal amount of the ...
Breaking Medicine Technology:First Quarter Results fiscal year ended September 30, 2015 - Ergoresearch reports its results for the quarter ended September 30, 2014. 2First Quarter Results fiscal year ended September 30, 2015 - Ergoresearch reports its results for the quarter ended September 30, 2014. 3First Quarter Results fiscal year ended September 30, 2015 - Ergoresearch reports its results for the quarter ended September 30, 2014. 44 Advantages of Laser Back Surgery When Fixing a Herniated Disk 2Valeant Announces Redemption of US$445.0 Million Aggregate Principal Amount of its Outstanding 6.875% Senior Notes due 2018 2
... redistributing its 196 beds to include a third location in ... service capabilities and better meet the needs of medically complex ... two locations: the Main Campus at 225 Penn Avenue and ... Hospital Suburban Campus at 100 South Jackson Avenue.   ...
... YORK, Oct. 5 Reportlinker.com announces that a ... catalogue: Global Vertebral Compression Fracture ... This report analyzes the Global market ... Annual estimates and forecasts are provided for the ...
Cached Medicine Technology:LifeCare Hospitals of Pittsburgh Opening Third Location 2Reportlinker Adds Global Vertebral Compression Fracture Devices Industry 2Reportlinker Adds Global Vertebral Compression Fracture Devices Industry 3Reportlinker Adds Global Vertebral Compression Fracture Devices Industry 4Reportlinker Adds Global Vertebral Compression Fracture Devices Industry 5
(Date:11/28/2014)... Written and narrated by award winning author ... the “The Happiest Man In the World: Life Lessons ... how and why Project C.U.R.E. came to be. , Raised ... and the Reverend Richard W. Jackson, Dr. Jackson exceeded his ... but realized that he wasn’t happy. Prompted by this realization, ...
(Date:11/28/2014)... Alex Kramer HealthDay Reporter ... kids involved in the kitchen, through cooking classes or at ... according to a recent review. Cooking programs and classes ... behaviors, according to the new research. And, although the review ... suggest that such programs might help children develop long-lasting healthy ...
(Date:11/28/2014)... An inventor and dental assistant from Kent, ... filling and it was almost impossible to reach. "This gave ... said. , The patent-pending Access Light allows for easier use ... of the mouth, as well as avoids harm to the ... to use and clean, it also helps prevent cross-contamination. , ...
(Date:11/28/2014)... York (PRWEB) November 28, 2014 ... ) have now been filed in a New ... metal implants, Bernstein Liebhard LLP reports. , ... Bergen County Superior Court reflects the filing of ... modular-neck hip stems, which were voluntarily recalled on ...
(Date:11/28/2014)... (PRWEB) November 28, 2014 Lice Troopers Lice ... of its in-home head lice service for moms in ... the center of Coral Gables on Pone De-leon Blvd in ... Harbor Islands that service Miami-Dade & Broward. Lice Troopers ... in South Florida which has been treating families for several ...
Breaking Medicine News(10 mins):Health News:Thanksgiving Weekend Audiobook Treat! “The Happiest Man In the World: Life Lessons From a Cultural Economist” by Dr. James W. Jackson 2Health News:Want Kids to Eat Better? Get Them Cooking 2Health News:Want Kids to Eat Better? Get Them Cooking 3Health News:More than 2,100 Stryker Hip Lawsuits Included in New Jersey Litigation after Settlement Announcement, Bernstein Liebhard LLP Reports 2Health News:More than 2,100 Stryker Hip Lawsuits Included in New Jersey Litigation after Settlement Announcement, Bernstein Liebhard LLP Reports 3Health News:Lice Troopers Lice Removal Service Expands in Miami-Dade 2
... they attributed symptoms to stress, indigestion and fatigue , , ... ignore or simply don,t recognize the warning signs of ... typical "Hollywood heart attack." , So say the authors ... Heart Association,s annual Scientific Forum on Quality of Care ...
... May 2 In an effort to ... requirements enforced by OSHA, EPA as,well as ... http://www.MSDSonline.com ), a leader in on-demand Material ... Safety (EH&S) management services,today announced the availability ...
... reports find , , FRIDAY, May 2 (HealthDay News) -- Working ... cost the American public $45 billion a year, a new ... of Medicaid and the State Children,s Health Insurance Program, and ... federal, state and local governments and shifted to other payers. ...
... CHICAGO According to a recent study, led by ... and assistant professor of medicine, Northwestern University Feinberg School ... a number of metabolic processes, may increase a womans ... important step forward in cancer genetics research, as it ...
... ... Membership Category, LITTLE ROCK, Ark., May 2 ... of an enhanced website at, http://www.NTOCC.org . The redesigned site contains ... of care challenges and to,raise awareness about transitions of care. Specific ...
... WASHINGTON, May 2 The Lupus Foundation of,America joins ... observing World Lupus Day on May 10. More than ... face an unpredictable,future as they struggle daily with the ... Lupus is the result of an unbalanced immune system ...
Cached Medicine News:Health News:Younger Women Often Miss Signs of Heart Attack 2Health News:Younger Women Often Miss Signs of Heart Attack 3Health News:MSDSonline Expands On-Demand Training Offering 2Health News:Government Picks Up Health Tab of Uninsured Workers 2Health News:Government Picks Up Health Tab of Uninsured Workers 3Health News:Government Picks Up Health Tab of Uninsured Workers 4Health News:Study shows gene variations may predict risk of breast cancer in women 2Health News:Healthcare Coalition Launches Enhanced Website Offering Tools and Materials to Improve Patient Care During Transitions of Care 2Health News:Healthcare Coalition Launches Enhanced Website Offering Tools and Materials to Improve Patient Care During Transitions of Care 3Health News:Healthcare Coalition Launches Enhanced Website Offering Tools and Materials to Improve Patient Care During Transitions of Care 4Health News:Healthcare Coalition Launches Enhanced Website Offering Tools and Materials to Improve Patient Care During Transitions of Care 5Health News:Lupus Organizations Issue International Call-to-Action to Combat Disease Affecting Five Million People 2
... a fast and versatile automated strip washer which ... is a self contained and programmable instrument. It ... from the gentle dripping of a simple squeeze ... systems. ELx50/12V processes 1 x 12 strips or ...
... High throughput washer for ... high throughput system washer ... more powerful dispensing line ... a stronger, external vacuum ...
High-quality microplate washer with robot compatibility. It offers additional washing capacity, first-rate efficiency in high-throughput and research applications....
The Wellwash 4 Mk 2 combines high performance and flexibility with reliability, simplicity and ease of use....
Medicine Products: