| Add to balance / Manage account | User: | Log out |
| Prospect News home > News index > List of issuers Q > Headlines for Questcor Pharmaceuticals, Inc. > News item |
Questcor to seek FDA approval of Acthar gel to treat infant seizures
By Elaine Rigoli
Tampa, Fla., Aug. 23 - The Food and Drug Administration has accepted for review Questcor Pharmaceuticals, Inc.'s supplemental New Drug Application seeking approval for H.P. Acthar gel (repository corticotropin injection) for the treatment of infantile spasms.
Questcor said it anticipates that the FDA will take action on the sNDA during the second quarter of 2007.
The sNDA provides clinical data to support the addition of the infantile spasms indication to the current Acthar gel label. Supportive information includes historical data on the use of Acthar gel in the treatment of infantile spasms, including the results from randomized clinical trials involving greater than 250 patients, which were published in peer-reviewed medical literature.
The company noted that no drug is approved in the United States for the treatment of infantile spasms, a seizure disorder of early childhood also known as West syndrome.
The onset is predominantly in the first year of life, typically between three to six months. The typical pattern is a sudden bending forward and stiffening of the body, arms and legs, although there can also be arching of the torso. Spasms tend to begin soon after arousal from sleep, according to a news release.
"Acthar gel is an important drug today in the treatment of infantile spasms. However, we believe this filing supports an even greater role for Acthar gel in managing this life-threatening form of childhood epilepsy. We look forward to working closely with the FDA throughout this review process," president and chief executive officer James Fares said in the release.
Questcor is a specialty pharmaceutical company based in Union City, Calif.
© 2015 Prospect News.
All content on this website is protected by copyright law in the U.S. and elsewhere.
For the use of the person downloading only.
Redistribution and copying are prohibited by law without written permission in advance from Prospect News.
Redistribution or copying includes e-mailing, printing multiple copies or any other form of reproduction.