LEVERKUSEN (dpa-AFX) - Bayer HealthCare(BAYZF.PK, BAYRY.PK, BYR.L), Wednesday said that the United States Food and Drug Administration or FDA approved Adempas or riociguat tablets for use in two forms of pulmonary hypertension.
Adempas is the only treatment approved in the US for use in two types of pulmonary hypertension. Bayer also said that it is the only FDA-approved drug therapy for chronic thromboembolic pulmonary hypertension or CTEPH that is inoperable or persistent/recurrent after surgical treatment. Earlier last month, the tablets were approved in Canada in the CTEPH indication.
'The clinical studies CHEST-1 and PATENT-1 met their primary endpoint by demonstrating a statistically significant improvement,' the company said.
The Phase III trial programs CHEST and PATENT are ongoing with the long-term extension studies, CHEST-2 and PATENT-2. In February 2013, Bayer HealthCare submitted riociguat for regulatory approval in the European Union and in May 2013 in Japan.
Copyright RTT News/dpa-AFX
© 2013 AFX News
