Achillion up after FDA lifts sovaprevir hold

Achillion Pharmaceuticals Inc. (NASDAQ:ACHN) jumped $3.54 (83%) to $7.79 on Tuesday after disclosing that FDA lifted a partial clinical hold on HCV compound sovaprevir. The company can now evaluate sovaprevir at a maximum dose of 200 mg once daily in HCV patients and in single dose trials in healthy volunteers. FDA is maintaining a partial clinical hold for multiple dose trials in healthy volunteers. FDA placed the hold on the compound last June after a Phase I drug-drug interaction trial showed sovaprevir plus ritonavir-boosted atazanavir led to elevations of liver enzymes in healthy volunteers.

Last September, Achillion announced it had addressed all of FDA's issues related to the hold, but that the agency felt the removal of the hold was "not warranted." According to Achillion, FDA requested additional analysis of pharmacokinetics and factors that may have led to "higher than anticipated exposures" of sovaprevir and the observed liver enzyme elevations, as well as analysis of other potential toxicities. Sovaprevir is a selective inhibitor of HCV NS3 protease (see BioCentury Extra, Sept. 27, 2013). ...