Navigation Links
Bayer Submits New Drug Application for Riociguat for the Treatment of Pulmonary Arterial Hypertension and Persistent/Recurrent Chronic Thromboembolic Pulmonary Hypertension

WAYNE, N.J., Feb. 11, 2013 /PRNewswire/ -- Bayer HealthCare today announced that the company has submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for riociguat, an investigational compound for the treatment of pulmonary arterial hypertension (PAH) and persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH.

"Bayer is submitting an NDA for riociguat for the treatment of two distinct forms of pulmonary hypertension.  If approved, riociguat would be the first pharmacological treatment for CTEPH, and it would have the potential to add an important new treatment option to the armamentarium for PAH," said Pamela A. Cyrus , MD, Vice President and Head of U.S. Medical Affairs, Bayer HealthCare Pharmaceuticals.  "The submission of riociguat is an important milestone in our cardio-pulmonary pipeline and is an example of Bayer's commitment to advancing treatment for hard to treat diseases."

The submission is supported by data from two global Phase III studies of riociguat CHEST-1 and PATENT-1.  Data from these two studies were presented in October 2012 at CHEST 2012, the annual meeting of the American College of Chest Physicians (ACCP).  Both Phase III studies on riociguat met their primary endpoint.

CHEST (Chronic Thromboembolic Pulmonary Hypertension sGC-Stimulator Trial) is a
Phase III trial to assess the efficacy and safety of oral riociguat in the treatment of patients with either inoperable CTEPH or CTEPH which has persisted or reoccurred after pulmonary endarterectomy (PEA). CHEST is a multi-center, multi-national program with active centers in 26 countries. The program includes a randomized, double-blinded, placebo-controlled trial phase (CHEST-1) and an open label extension trial phase (CHEST-2).

In the CHEST-1 study, 261 patients with inoperable CTEPH or with persistent or recurrent CTEPH after PEA were randomized and treated with either riociguat or placebo orally for 16 weeks. The primary endpoint of the trial was improvement in 6-minute walking distance. Riociguat was titrated, over a period of eight weeks in doses of 0.5 mg increments, from 1.0 mg up to 2.5 mg, three times a day. After the titration phase, patients were followed up for another eight weeks on their last dose to complete CHEST-1. Patients from both arms then had the option of participating in the open label extension study (CHEST-2) after completing an eight-week blinded sham titration. CHEST-2 is continuing to investigate riociguat in CTEPH patients.  Results of CHEST-2 will be presented at an upcoming scientific congress in 2013.

PATENT (Pulmonary Arterial Hypertension sGC-Stimulator Trial) is a Phase III trial to assess oral riociguat in the treatment of treatment naïve patient and pre-treated patients with symptomatic PAH.  PATENT is a multi-center, multi-national program with active centers in 32 countries. The program includes a randomized, double-blind, placebo-controlled trial phase (PATENT-1) and an open label extension trial phase (PATENT-2).

In the PATENT-1 study, 445 patients with symptomatic PAH were randomized to receive either placebo or two different doses of riociguat orally over a period of 12 weeks.  . The primary endpoint of the trial was improvement in 6-minute walking distance. The riociguat dose was titrated, over a period of eight weeks in doses of 0.5 mg increments from 1.0 mg up to 2.5 mg three times daily. Patients were then followed for an additional four weeks to complete the study. Patients then had the option of participating in the open label extension study, after completing an eight-week blinded sham titration.

About Riociguat
Riociguat (BAY 63-2521), discovered and developed at the Bayer research laboratories, is an investigational oral soluble guanylate cyclase (sGC) stimulator that is being studied in CTEPH and PAH, as well as other forms of pulmonary hypertension. Riociguat is an investigational agent and is not approved by the FDA, EMA or other health authorities.  

About Bayer HealthCare Pharmaceuticals Inc.
Bayer HealthCare Pharmaceuticals Inc. is the U.S.-based pharmaceuticals business of Bayer HealthCare LLC, a subsidiary of Bayer AG. Bayer HealthCare is one of the world's leading, innovative companies in the healthcare and medical products industry, and combines the activities of the Animal Health, Consumer Care, Medical Care, and Pharmaceuticals divisions.  As a specialty pharmaceutical company, Bayer HealthCare provides products for General Medicine, Hematology, Neurology, Oncology and Women's Healthcare.  The company's aim is to discover and manufacture products that will improve human health worldwide by diagnosing, preventing and treating diseases.

Bayer® and the Bayer Cross® are registered trademarks of Bayer.

Forward-Looking Statements
This release may contain forward-looking statements based on current assumptions and forecasts made by Bayer Group or subgroup management. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in Bayer's public reports which are available on the Bayer website at The company assumes no liability whatsoever to update these forward-looking statements or to conform them to future events or developments.

Intended for U.S. media only 

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

Related medicine technology :

1. Bayer Consumer Care Voluntarily Recalls 56 Lots of BRONKAID Caplets Dual Action Formula due to Product Labeling Error
2. Bayers Second Annual Virtual Walk for Hemophilia Raises Funds, Generates Excitement in the Hemophilia Community
3. MediSapiens to Provide Bayer HealthCare Pharmaceuticals With a New Cloud Computing Application to Analyze and Visualize Multi-Dimensional Genomics Data
4. MediSapiens liefert neue Cloud-Computing-App zur Analyse und Visualisierung multidimensionaler Genomdaten an Bayer HealthCare Pharmaceuticals
5. MediSapiens sapprête à fournir à Bayer HealthCare Pharmaceuticals une nouvelle application informatique en nuage pour analyser et visualiser les données génomiques multidimensionnelles
6. Hagens Berman Sobol Shapiro LLP and Douglas & London P.C. Announce Proposed Class Action Settlement in Bayer Combination Aspirin Products Litigation
7. Bayer Submits New Drug Application for Regorafenib for the Treatment of Gastrointestinal Stromal Tumors (GIST)
8. U.S. FDA Grants Priority Review to the New Drug Application for Bayers Regorafenib to Treat Patients with Metastatic Colorectal Cancer
9. Zacks Bull and Bear of the Day Highlights: Discover Financial Services, POSCO, AstraZeneca, Bayer and Takeda Pharmaceutical
10. Bayer Partnership Delivers Industry-First Dose Management Offering
11. Regeneron and Bayer Announce Co-Promotion Agreement With Santen For EYLEA® (aflibercept) Injection in Japan
Post Your Comments:
(Date:11/26/2015)... DUBLIN , Nov. 26, 2015 Research and ... "Asia Pacific Cardiac Pacemaker Market Outlook to 2019 - ... Drive the Demand " report to their offering. ... --> Boston scientific and others. ... global players including Medtronic, Biotronik, Boston ...
(Date:11/26/2015)... DUBLIN , November 26, 2015 /PRNewswire/ ... the addition of the "2016 Future ... Drugs of Abuse Testing Market: Supplier Shares, ... report to their offering. --> ... of the "2016 Future Horizons and ...
(Date:11/26/2015)... , November 26, 2015 ... Juntendo universitetssjukhus ser potential att använda ... magnetresonansbilder (MR-bilder) för patienter med multipel ... ett forskningsavtal med SyntheticMR AB för att ... forskningsprojekt på sjukhuset. Med SyMRI kan man ...
Breaking Medicine Technology:
(Date:11/27/2015)... , ... November 27, 2015 , ... A team of ... ways to treat it. Surviving Mesothelioma has just posted the findings on the website. ... Hospital Zurich analyzed the cases of 136 mesothelioma patients who were treated with chemotherapy ...
(Date:11/27/2015)... ... 27, 2015 , ... ProSidebar: Fashion is a set of 30 ... ProSidebar: Fasion, video editors can easily add an informative sidebar to any FCPX production. ... Utilize presets featuring self-animating drop zones, lines, bars, and text with the ease of ...
(Date:11/27/2015)... ... 27, 2015 , ... The moment you stop improving is ... fulfilling the needs of advisers and clients but going above and beyond to ... customer service. However, there's always room for improvement, which is why the entire ...
(Date:11/27/2015)... ... 2015 , ... Avid collector, Andrew Hawley from Vintage Rock Posters, announces his ... is one of Joplin's most famous and beautiful concert posters. The concert was held ... Ann Arbor. The According to Hawley, "It is hard to believe that Joplin's stardom ...
(Date:11/26/2015)... ... November 26, 2015 , ... ... Travel Representative. As a franchise owner, Somu now offers travelers, value and care ... wedding packages, private cruise sales, as well as, cabin upgrades and special amenities ...
Breaking Medicine News(10 mins):