US FDA approves Novartis Afinitor for SEGA, Forest's Teflaro for CABP and Avanir's Nuedexta for PBA

The US Food and Drug Administration has approved Swiss drug major Novartis’ (NOVN: VX) Afinitor (everolimus) tablets for patients with subependymal giant cell astrocytoma (SEGA), a benign brain tumor associated with tuberous sclerosis (TS), who require therapeutic intervention but are not candidates for curative surgical resection.

The drug was cleared by the FDA last year for the treatment of renal cell carcinoma (The Pharma Letter April 1, 2009). Afinitor achieved sales of $67 million in the third quarter of this year for the treatment of patients with RCC.

The accelerated US approval of Afinitor for SEGA is based on an open-label, single-arm, 28-patient study conducted by Cincinnati Children's Hospital Medical Center. The effectiveness of the drug is based on an analysis of change in SEGA volume. A Phase III study is underway that compares Afinitor to placebo to explore the clinical benefits of Afinitor for the treatment of patients with SEGA associated with TS.