ARTICLE | Company News
CHMP rebuffs Portola's betrixaban, Radius' abaloparatide-SC
March 23, 2018 9:59 PM UTC
EMA's CHMP issued negative opinions on Friday for Dexxience betrixaban from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) and Eladynos abaloparatide-SC from Radius Health Inc. (NASDAQ:RDUS).
The committee recommended against approval of Dexxience to prevent venous thromboembolism (VTE) in adult patients hospitalized for an acute medical illness with risk factors for VTE, including VTE-related death. Portola said it plans to request a re-examination of the MAA. In February, the company said CHMP communicated a "negative trend vote" for the Dexxience MAA...