ADELPHI, Md., May 6 (Reuters) - Questcor Pharmaceuticals Inc's Acthar gel is safe and effective for treating certain seizures in infants, a panel of medical experts told the U.S. Food and Drug Administration on Thursday.
The panel voted 22-1 in favor of the drug's efficacy in treating spasms in infants. It voted 20-1, with two members abstaining, that there was enough evidence backing the drug's safety, although panelists were mixed over how manageable and reversible the complications were.
Acthar is already widely used by doctors to treat infantile spasms, a form of epilepsy, even without FDA consent. Questor has been seeking the agency's formal approval for years, saying it will help standardize care and offer specific guidelines for dosing.
The drug was first approved in 1952 for a range of uses, including multiple sclerosis.
The FDA is expected to make the final decision by June 11. The FDA usually, but not always, follows its panel's advice.
Shares of the drugmaker were halted on Thursday pending the outcome of the meeting.
(Reporting by Susan Heavey. Editing by Robert MacMillan) Keywords: QUESTCOR ACTHAR/ (sheavey@thomsonreuters.com; +1 202-354-5848; www.twitter.com/ReutersDChealth) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
The panel voted 22-1 in favor of the drug's efficacy in treating spasms in infants. It voted 20-1, with two members abstaining, that there was enough evidence backing the drug's safety, although panelists were mixed over how manageable and reversible the complications were.
Acthar is already widely used by doctors to treat infantile spasms, a form of epilepsy, even without FDA consent. Questor has been seeking the agency's formal approval for years, saying it will help standardize care and offer specific guidelines for dosing.
The drug was first approved in 1952 for a range of uses, including multiple sclerosis.
The FDA is expected to make the final decision by June 11. The FDA usually, but not always, follows its panel's advice.
Shares of the drugmaker were halted on Thursday pending the outcome of the meeting.
(Reporting by Susan Heavey. Editing by Robert MacMillan) Keywords: QUESTCOR ACTHAR/ (sheavey@thomsonreuters.com; +1 202-354-5848; www.twitter.com/ReutersDChealth) COPYRIGHT Copyright Thomson Reuters 2010. All rights reserved. The copying, republication or redistribution of Reuters News Content, including by framing or similar means, is expressly prohibited without the prior written consent of Thomson Reuters.
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