FDA to review Hemispherx drug in December
PHILADELPHIA (AP) — Shares of Hemispherx Biopharma Inc. fell Monday after the drugmaker said that the Food and Drug Administration has scheduled a meeting for December to review its experimental drug for chronic fatigue syndrome.
The Food and Drug Administration has tentatively scheduled an advisory committee meeting for Dec. 20, where a panel of experts will discuss the safety and efficacy of the company's drug, Ampligen. The FDA is not required to follow the advice of its panelists, though it often does. The agency is scheduled to make its final decision on the drug by Feb. 2.
The FDA previously rejected the injectable drug in late 2009, citing two key studies as not proving the drug is effective. Also, the FDA noted manufacturing issues that need to be resolved.
Shares of the Philadelphia company fell 7 cents, or 6.8 percent, to 93 cents in late trading.