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FDA advisory panel supports use of Acthar for treating infantile spasms

Wednesday, May 12 2010 | Comments

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What's This? An advisory panel to the Food and Drug Administration supports the use of H.P. Acthar Gel (repository corticotropin injection), or Acthar, as a treatment for patients with infantile spasms.

In a 22-1 vote, members of the Peripheral and Central Nervous System Drugs Advisory Committee indicated that the drug is effective for treating infantile spasms, while a 20-1 vote, with 2 abstentions, reflected the panel's opinion that sufficient data exist to back Acthar's safety.

However, certain panel members expressed some concern regarding the complications associated with the use of the injection. Specifically, members of the advisory committee voted 12-10, with 1 abstention, that Questcor Pharmaceuticals Inc. had not provided evidence that adverse effects associated with the drug's use are manageable and reversible.

FDA staff previously noted that the injection was approved in 1952 and has been the standard of care for treating infantile spasms for many years. Questcor sought formal approval for this indication in 2006 but received a not approvable letter from the FDA in 2007. The agency recommended that the company, which had not conducted any studies of its own, find trial data in the published literature to support its application.

Prior to the panel's decision, FDA reviewers indicated in premeeting documents that the data Questcor submitted to accompany its supplemental New Drug Application (sNDA) "differ considerably from that typically submitted."

Questcor had maintained that the only approved drug for this indication, vigabatrin, has a lower response rate than that seen with Acthar and is associated with risk of permanent vision loss. The firm had also stated that it was important for physicians to have other options to treat this condition.

The FDA has established June 11 as the Prescription Drug User Fee Act action date for the sNDA, according to Questcor.

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