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February 4, 2021updated 28 Oct 2021 1:13pm

LoA Update: Allergan’s CVC for NASH sees a 17 point drop in FDA approval potential due to Phase III trial termination

By GlobalData Healthcare

As of 13 January, the likelihood of approval (LoA) for Allergan -Plc/”>Allergan ’s cenicriviroc (C VC ) for NASH in the US fell 17 points, according to GlobalData’s LoA data. The score change was based on the Phase III AURORA trial registry page getting updated to note that the study has been terminated due to Part I results showing lacking efficacy.

While the LoA prior to this update was 20%, GlobalData’s analysis using a combination of machine learning and a proprietary algorithm has lowered the LoA to 3%. Allergan is now part of AbbVie , which announced the closing of the acquisition—valued at approximately $63bn—on 8 May 2020. AbbVie ’s market cap is $183.11bn.

C VC trial results were underwhelming

In November 2018, this news service reported that C VC drew mixed expert sentiments for Phase III AURORA trial success. The Phase II C ENTAUR results demonstrated an underwhelming inflammation impact, and the observed placebo effect made available data harder to interpret, interviewed experts noted.

In fact, the foggy Phase IIb data may have contributed to AURORA patient accrual delays, this news service subsequently reported 13 April 2019. Two sources familiar with the trial said at the time that AURORA was notably behind its enrolment target. AURORA enrolled its first patient on 20 April 2017 and aimed to recruit a total of 1,779 participants, according to C linicalTrials.gov.

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