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Questcor Gains Approval of Acthar for Infantile Spasms

This article was originally published in The Pink Sheet Daily

Executive Summary

Long prescribed off-label, the adrenocorticotropic hormone also gets an orphan designation, bringing seven years of market exclusivity.

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Questcor Expansion Strategy Pays Off For Acthar

Questcor has successfully revived a decades-old product by raising the drug’s price, securing a new approval in a niche orphan indication in infants and making a commercial push in areas like multiple sclerosis and rheumatoid arthritis.

No Longer Under The Radar: Aetna Narrows Coverage For Questcor’s Acthar

Aetna’s decision to no longer cover Acthar in patients with multiple sclerosis or nephrotic syndrome suggests the cost of covering the high-priced niche drug has grown to the point that it is prompting closer scrutiny; promotional campaign has also drawn government review.

Acthar PDUFA Date Delayed As FDA Reviews Post-Approval Commitments

Advisory committee had recommended trials on side effects, sustainability, dosing and safety for the infantile spasms indication, which the firm was concerned would be unethical.

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