The Tuberous Sclerosis Alliance is pleased to announce that the U.S. Food and Drug Administration (FDA) has accepted two new drug applications from Ovation Pharmaceuticals, Inc. for Sabril® (vigabatrin) addressing two types of epilepsy, including infantile spasms. This is exciting news for the TSC community because this is the first step toward review and hopefully approval of vigabatrin for use in the U.S.A. Vigabatrin is currently marketed in more than 50 countries worldwide.
The Tuberous Sclerosis Alliance is advocating for an expedited review of the application, but we anticipate the process will take six to nine months. We will keep you informed as we find out more over the coming weeks.
Infantile spasms are a somewhat rare, but catastrophic, form of epilepsy, which almost always start before one year of age. They are one of many symptoms that arise from TSC and about 50 percent of children with tuberous sclerosis complex experience infantile spasms. Currently, there is only one off-label treatment for infantile spasms. Sabril (vigabatrin) would be the first FDA approved treatment. “Effective treatment options in the United States for infantile spasms are rare,” said Kari Luther Carlson, CEO of the TS Alliance, “and this is a positive step for our community.”
For complete information, read the news release from OVATION here.