The announcement was made at the American Thoracic Society International Conference in Philadelphia, where Kemal Malik, head of global development at Bayer Healthcare, explained that riociguat, which was the open-label long-term extension of the Phase III study PATENT-1, demonstrated promising results.
Even though there are currenty several approved treatment therapries, mortality rates among PAH patients remain high and the general prognosis is still poor. However, Bayer is confident that results from its clinical trial would highlight the benefits of riociguat, which would be a powerful tool in the battle against PAH, Malik added.
The interim analysis of PATENT-2 showed that riociguat was well tolerated and demonstrated a good long-term safety profile in patients who have been previously treated and those who have not ungergone PAH treatment. Headache, dizziness, dyspepsia and hypotension were the most common adverse effects of the drug, the analysis revealed.
Riociguat was recently granted a priority review by the US Food and Drug Administration (FDA), regarding its US approval, Bayer pointed out in a statement.
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