Novartis, the Swiss pharmaceutical company said this week on Saturday that the US Food and Drug Administration (FDA) has given its approval to their drug which is meant for the treatment of some benign tumors of the brain which needed surgery earlier.
The drug by Novartis, Everolimus, which is known by the name Afinitor, has proved to be effective in the reduction of subependymal giant cell astrocytoma (SEGA) which is linked to tuberous sclerosis.
Tuberous sclerosis is a genetic disorder which affects approximately 25,000 to 40,000 people most of who are children and adolescents in the United Stated.
The drug was approved under the accelerated approval program of the FDAand was based on the study done on 28 patients by Cincinnati Children's Hospital Medical Center, wherein almost one-third patients felt a reduction of
50 percent or more in the size of their SEGA in just six months time.
Novartis said that it was still studying the clinical advantages and efficiency of the drug in a much wider study. On the other hand it said that it had submitted marketing applications to the European Medicines Agency and the Swiss Agency for Therapeutic Products.
