Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction
UsernamePublicRestriction

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.

You may also be interested in...



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.

Related Content

Topics

UsernamePublicRestriction

Register

PS071312

Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel