Achillion’s Hepatitis C Drug Still on Hold by U.S. FDA
Achillion Pharmaceuticals Inc. (ACHN) said U.S. regulators are keeping the company’s experimental hepatitis C drug sovaprevir on hold because of abnormal liver results. The shares plunged 45 percent in extended trading.
While Achillion responded to all the issues raised by the Food and Drug Administration in June, the agency determined the drug’s development shouldn’t resume, the New Haven, Connecticut-based company said today in a statement. Achillion will focus on other hepatitis C drugs in its portfolio, with results of a planned combination study of two medications by next year, Chief Executive Officer Milind Deshpande said.
“While we are disappointed that we were not able to resolve the clinical hold at this time despite having addressed all the issues, we believe the breadth of our portfolio allows us to quickly advance other all oral combination regimens for the treatment of HCV,” Deshpande said in the statement.
High levels of liver enzymes, which can indicate damage, were observed in healthy patients when sovaprevir was combined with two medicines used to treat HIV infections, the company said in July. The tests were performed to look for possible drug interactions. The combination may have resulted in higher-than-expected blood levels of the therapies, Achillion said in July.
Achillion has three drugs in clinical testing for hepatitis C, a liver disease estimated to affect 170 million people worldwide. It is competing with drugmakers including AbbVie Inc. (ABBV) and Gilead Sciences Inc. (GILD) to develop new treatments for the disease, a market analysts’ estimate may be $20 billion.
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