Updated on 30 August 2012
Afinitor Disperz should be used only in patients with TSC who require treatment for SEGA that cannot be surgically removed. The most common side effects observed in patients with SEGA were mouth ulcers and respiratory tract infections.
Afinitor and Afinitor Disperz remain under accelerated approval for the treatment of SEGA in patients with TSC. Studies are ongoing to further evaluate the long-term safety and effectiveness of Afinitor and Afinitor Disperz in pediatric and adult patients with SEGA. Afinitor Disperz is classified as an orphan drug because it is intended to treat a rare disease or condition. Afinitor Disperz's application was granted priority review, which FDA completed in six months.