Questcor Gains Approval of Acthar for Infantile Spasms
This article was originally published in The Pink Sheet Daily
Long prescribed off-label, the adrenocorticotropic hormone also gets an orphan designation, bringing seven years of market exclusivity.
You may also be interested in...
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.
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.
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.