BioCentury
ARTICLE | Clinical News

Negative CHMP opinion for Portal VTE candidate

March 30, 2018 5:47 PM UTC

EMA's CHMP recommended against approval of Dexxience betrixaban from Portola Pharmaceuticals Inc. (NASDAQ:PTLA) 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 (see BioCentury, Feb. 23).

Portola markets betrixaban as Bevyxxa in the U.S. for the indication. Its label carries a black box warning describing elevated risk of epidural or spinal hematoma in patients receiving neuraxial anesthesia or undergoing spinal puncture (see BioCentury, July 5, 2017)...

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