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Sarepta Therapeutics, Inc. Message Board

  • zwerp2000 zwerp2000 Feb 11, 2013 6:50 PM Flag

    Anyone see this article?

    Innovative Drugs May Win U.S. Approval After Early Trials

    By Anna Edney & Catherine Larkin - Feb 11, 2013 5:26 PM ET.

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    Drugmakers may win approval from U.S. regulators for “breakthrough” therapies after a single round of studies, rather than three, in an effort to speed them to patients, a Food and Drug Administration official said.

    The agency assigned three promising experimental medicines the new status to try to reduce the time needed to get them to market against life-threatening diseases, Janet Woodcock, director of the FDA’s Center for Drug Evaluation and Research, said today in an interview before a Bloomberg State of Health Care conference in New York. Vertex Pharmaceuticals Inc. said last month that two of its drugs for cystic fibrosis had won the designation.

    Breakthrough status means the companies will have closer communication with top FDA staff to move drugs for serious diseases to market more quickly, potentially with data from an expanded Phase 1 trial, Woodcock said. Improved understanding of diseases is leading to more candidates for this status.

    “We expect many of these would come available very quickly with Phase 1 data,” Woodcock said.

    New drugs generally need three phases of testing focusing on safety and effectiveness to win FDA regulatory approval.

    In addition to the three treatments that have won the new designation, 18 other drugs have applied to gain the new status, most for types of cancer, Woodcock said.

    The breakthrough designation was created in legislation passed last year reauthorizing the FDA’s user fee programs for drug and device reviews. The agency didn’t receive authorization to hire additional full-time employees for the enhanced communication and is attempting to balance its priorities.

    “We don’t want to disadvantage ordinary drugs,” Woodcock said.

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