Bayer's Investigational Riociguat Granted U.S. FDA Priority Review for
Pulmonary Arterial Hypertension and Inoperable or Persistent/Recurrent Chronic
Thromboembolic Pulmonary Hypertension
WAYNE, N.J., April 8, 2013
WAYNE, N.J., April 8, 2013 /PRNewswire/ --Bayer HealthCare announced today
that the New Drug Application (NDA) for its oral investigational compound
riociguat has been accepted for filing and granted priority review by the U.S.
Food and Drug Administration (FDA) for the treatment of inoperable chronic
thromboembolic pulmonary hypertension (CTEPH) or with persistent or recurrent
CTEPH after pulmonary endarterectomy (PEA) and pulmonary arterial hypertension
Both CTEPH and PAH are life-threatening diseases. CTEPH is a form of
pulmonary hypertension in which blood clots and thromboembolic occlusion of
pulmonary vessels leads to increased pressure in the pulmonary arteries. PAH
is a disease characterized by elevated pressure in the pulmonary arteries.
"We are pleased that the FDA has granted priority review of the riociguat NDA
for two distinct forms of pulmonary hypertension," said Pamela A. Cyrus, MD,
Vice President and Head of U.S. Medical Affairs, Bayer HealthCare
Pharmaceuticals. "This milestone reinforces our commitment to advancing
treatment options for cardio-pulmonary diseases, and brings us one step closer
to potentially providing the first pharmacological treatment for inoperable or
persistent/recurrent CTEPH and a new treatment option for PAH."
The FDA grants priority review to medicines that provide a treatment where
little or no adequate therapy exists. Under the Prescription Drug User Fee Act
(PDUFA), the FDA aims to complete its review within six months of the 60-day
filing receipt of the NDA submission (eight months total), rather than the
standard 12-month review cycle.
The NDA 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, the annual meeting of the American College of Chest
Physicians (ACCP). Both Phase III studies on riociguat met their primary
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.
PATENT (Pulmonary Arterial Hypertension sGC-Stimulator Trial) is a Phase III
trial to assess oral riociguat in the treatment of treatment naive 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
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.
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.
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SOURCE Bayer HealthCare
Contact: Marcy Funk, Communications, Bayer HealthCare, Telephone: (973)
305-5385, E-Mail: email@example.com
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