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ARTICLE | Clinical News

Sovaprevir: FDA hold

July 15, 2013 7:00 AM UTC

Achillion said FDA placed a partial clinical hold on sovaprevir after a Phase I drug-drug interaction trial in 31 healthy volunteers showed that sovaprevir plus ritonavir-boosted atazanavir led to grade 3 elevations of alanine aminotransferase (ALT) levels in 3 subjects and grade 4 elevations in 2 subjects. Achillion said that while the ALT elevations did not meet the criteria for serious adverse events, preliminary pharmacokinetic data indicate that co-administration substantially increased plasma concentration of both sovaprevir and atazanavir. FDA requested data from 2 other drug-drug interaction studies and an integrated safety analysis of ongoing sovaprevir trials. Achillion expects to provide the requested data within about 6 weeks. ...