BioCentury
ARTICLE | Regulation

Rescripting PAH

Bayer's riociguat gives FDA new opportunity to shift how it evaluates PAH rugs

August 12, 2013 7:00 AM UTC

If FDA approves Bayer AG's entire dose titration scheme for Adempas riociguat, the agency will be departing from its past decisions on PAH drugs, which have been determined by significant improvements on six-minute walk distance, not by surrogate cardiopulmonary markers.

The agency's Cardiovascular and Renal Drugs Advisory Committee laid the groundwork last week...