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Questcor MS drug wins new indication

Questcor Pharmaceuticals has won US Food and Drug Administration approval of a new indication for its for HP Acthar Gel

Questcor Pharmaceuticals, which specialises in drugs for difficult-to-treat diseases, has won US Food and Drug Administration (FDA) approval of a new indication for its for HP Acthar Gel (repository corticotropin injection). The gel was initially cleared for marketing in the US in 1952 and is already sold for a range of indications, including use in multiple sclerosis.

The newest approval is for the treatment of infantile spasms (IS), an extremely rare, potentially fatal form of epilepsy that affects approximately 2,000 American infants and young children annually.

Acthar is already widely used off-label to treat the condition, based on guidelines published by the American Academy of Neurology and the Child Neurology Society. However, approval for the indication will allow Questcor to promote the product for the indication. "The FDA approval of Acthar for IS treatment provides an opportunity to begin raising awareness among healthcare providers and parents about the importance of early diagnosis and appropriate treatment of IS," Don M Bailey, president and CEO of Questcor, said in a statement.

In preparation for the launch of the new indication, Questcor is significantly expanding its Acthar sales force. The company said it intends to increase its marketing efforts in MS as well as focussing on the launch of the new IS indication, which will begin at the annual meeting of the Child Neurology Society next week.

The FDA approval will also help standardise care for IS by providing specific guidelines for physicians on prescribing Acthar, the company noted. The FDA's clearance includes the approval of new labelling and a new medication guide for the drug reflecting its use in the treatment of IS.

Acthar, which has orphan status for the new indication, has been granted seven years of marketing exclusivity in the US, during which time the FDA may not approve any other adrenocorticotropic hormone formulation for IS unless the other formulation is clinically superior.

In conjunction with the review of the supplemental marketing application for IS, the FDA has also approved an update of the label to include "other indications where there is evidence or scientific rationale for Acthar efficacy," including systemic lupus erythematosus, polymyositis and optic neuritis. The update also deletes dozens of "legacy" indications that did not generate revenue for the company.

The updated labelling now lists 19 indications, in categories including IS, multiple sclerosis, edematous state, rheumatic disorders, psoriatic arthritis, dermatologic diseases, and others.

15th October 2010

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