Questcor Pharmaceuticals, Inc announced that the commercial launch is now underway for HP Acthar Gel (repository corticotropin injection) as monotherapy for the treatment of Infantile Spasms (IS) in infants and children under the age of two years. This new Acthar indication was approved by the U.S. Food and Drug Administration (FDA) on October 15, 2010.
Acthar provides an important treatment option for children suffering from IS, an ultra-rare form of childhood epilepsy that afflicts an estimated 2,000 children in the US annually. While Acthar has been used by many child neurologists in the treatment of IS for more than 50 years, approval of the IS indication allows Questcor for the first time to engage in direct proactive dialogue with these physicians about Acthar dosing guidelines, adverse events and potential treatment benefits. It also allows the company to educate healthcare providers regarding the importance of early and aggressive treatment of IS. Additionally, the company can now provide direct support and educational materials to the parent and caregiver community about the signs and symptoms of IS and the availability of Acthar for this indication.
"With the launch of this new indication for Acthar, child neurologists and parents will now have greater access to vital information about Infantile Spasms, clear guidelines about the use of Acthar for IS, and additional support when dealing with this potentially catastrophic neurological disorder," said Don M Bailey, president and chief executive officer of Questcor. "FDA approval allows us to begin efforts to help raise awareness of IS and to provide information and support to parents and caregivers to help ensure children with IS receive the best possible care."
Through its newly updated product site, www.acthar.com, the company offers an electronic version of the new Acthar Medication Guide, which was designed to provide important information to parents and caregivers of children with IS being treated with Acthar. Additionally, an interactive video and Acthar Injection Guide walk parents and caregivers through important instructions on how to give Acthar injections. The site also hosts robust disease-state information, as well as a tool that allows parents and caregivers to speak directly to a specialist who can help answer any questions about Acthar or how to administer it.
"We have heard from many parents that the fear and confusion they experience when their child is diagnosed with IS can be overwhelming," said Steve Cartt, executive vice president and chief Business officer of Questcor. "With access to educational information and support resources, parents and caregivers can now have immediate access to the most up-to-date information available on IS, as well as to tools and administration guidelines on the appropriate use of Acthar."
HP Acthar Gel is a natural adrenocorticotropic hormone (ACTH) designed to provide a prolonged release after intramuscular or subcutaneous injection.
Questcor Pharmaceuticals is a biopharmaceutical company with products that help patients with serious, difficult-to-treat medical conditions.