FDA approves pediatric Afinitor from Novartis and Teva's tbo-filgrastim

The US Food and Drug Administration yesterday approved Swiss drug major Novartis’ (NOVN: VX) Afinitor Disperz (everolimus tablets for oral suspension), a new pediatric dosage form of this anti-cancer drug used to treat a rare brain tumor called subependymal giant cell astrocytoma (SEGA). Afinitor Disperz is the first approved pediatric-specific dosage form developed for the treatment of a pediatric tumor.

The drug is already approved by the FDA and European regulators to treat patients other types of cancer, including kidney, a rare type of pancreatic cancer and breast cancer; The Pharma Letters passim). First half 2012 sales of Afinitor in its current indications reached $318 million and analysts believe added indications will see the drug achieve peak annual sales in excess of $1 billion.

Afinitor Disperz is recommended to treat patients aged one year and older with tuberous sclerosis complex (TSC) who are diagnosed with SEGA that cannot be treated with surgery. Prior to approval of this new dosage form, Afinitor was recommended for use only in patients aged three years old and older. Afinitor was granted accelerated approval in 2010 to treat SEGA in patients with TSC.