Abbott under FDA scrutiny for psoriasis drug

By Bruce Japsen
Posted Jan. 14 at 10:59 a.m.

Abbott Laboratories this morning said it will hold off seeking U.S. approval of an experimental psoriasis treatment following feedback from federal regulators who have concerns about the drug.

Abbott would not disclose exactly what the concerns of the U.S. Food and Drug Administration are. The agency, however, has in recent years stepped up its scrutiny of the safety and efficacy of drugs and increasingly orders more study in clinical trials, particularly for safety risks to the heart.

The news hit the company’s stock. The price of Abbott’s shares lost 1 percent of their value or 49 cents, dipping to $46.88 in trading on the New York Stock Exchange.

“Following feedback from regulatory authorities indicating the need for further analysis and the potential for additional studies, the company plans to evaluate next steps for briakinumab, including resubmission at a later date,” Abbott said in a filing with the U.S. Securities and Exchange Commission.

In Europe, Abbott said it also withdrew its European “marketing authorization application.” The drug is derived from biotechnology.

Abbott said the drug is being studied in about 1,500 patients around the world and those studies are ongoing.

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