Achillion gets FDA Incentives for Hepatitis C Drug
NEW HAVEN, Conn. – May 15, 2012 – Achillion Pharmaceuticals Inc. said Tuesday it will receive incentives from regulators as it studies a new experimental treatment for the hepatitis C virus.
The Food and Drug Administration awarded fast track status to Achillion’s drug candidate ACH-3102. The agency’s decision will allow Achillion to file its application for marketing approval piece by piece instead of waiting to collect all the clinical trial data for the drug, and Achillion will be able to consult with the FDA more often as it develops the drug. The FDA may also choose to review the full application in six months instead of the usual 10 months.
Achillion said it started clinical trials of ACH-3102 on Wednesday. Those trials are intended to test the drug’s safety and its side effects rather than its effectiveness. The company plans to study a combination of ACH-3102 with its most advanced drug candidate, ACH-1625. Achillion hopes that combined, the drugs could be part of a hepatitis C a regimen that could treat the disease without interferon. Interferon is a common part of hepatitis C treatment but can cause serious side effects, including flu-like symptoms that can last for months.
Shares of Achillion gained 1 cent to $6.90 in midday trading. Earlier the stock rose as much as 7.4 percent.
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