Bayer reports positive phase 3 data for lung drug
Bayer has announced positive data from the interim analysis of its experimental riociguat drug to treat patients with pulmonary arterial hypertension (PAH).
In the extension of a phase 3 clinical trial, the drug was shown to sustain clinical benefits and long-term safety in PAH patients. Further improvements in six minute walking distance (6MWD) were seen with continued riociguat treatment. After an additional 12 weeks of treatment in the PATENT-2 trial, the 6MWD had increased further in former riociguat patients compared with baseline of the pivotal PATENT-1 trial. The former placebo patients improved to a similar extent.
“Despite the availability and advantages of several approved PAH therapies, the prognosis for patients remains poor and mortality remains high. The interim results of PATENT-2 support the benefits of riociguat that were seen in the PATENT-1 trial. We are confident that, together, these results reinforce the role of riociguat, if approved, as a new treatment in the armamentarium against PAH.”
Kemal Malik, member of the Bayer HealthCare Executive Committee and Head of Global Development.
Preliminary results of this study were published in October 2012, which encourage Bayer to submit riociguat for regulatory approval in both the US and Europe. The FDA recently granted the drug company with priority review for this drug’s US approval. If approved, Bayer expects the product’s peak annual sales to be over €500 million.
Don't miss your daily pharmaphorum news.
SUBSCRIBE free here.