FDA approves Novartis brain tumour drug

October 30, 2010

Swiss pharmaceutical company Novartis said Saturday that the US drug Food and Drug Administration had approved a drug for treating certain benign brain tumours which previously required surgery.

Everolimus, marketed as Afinitor, had been shown to be effective in reducing subependymal giant cell astrocytoma (SEGA) associated with tuberous sclerosis, a affecting approximately 25,000 to 40,000 people, mainly children and , in the United States, it said.

Accelerated FDA approval was based on a study of 28 patients conducted by Cincinnati Children's Hospital Medical Center, in which nearly one-third of experienced a reduction of 50 percent or more in the size of their largest SEGA within six months, Novartis said.

The company said it was continuing to study the efficacy and clinical benefit of Afinitor in a wider trial, and had submitted marketing applications to the European Medicines Agency and the Swiss Agency for Therapeutic Products (Swissmedic).

If approved in the European Union for this indication, the treatment will be made available under the trade name Votubia, it said.

Related Stories

Recommended for you

Opioid addiction treatment behind bars reduced post-incarceration overdose deaths in RI

February 14, 2018
A treatment program for opioid addiction launched by the Rhode Island Department of Corrections was associated with a significant drop in post-incarceration drug overdose deaths and contributed to an overall drop in overdose ...

Heroin vaccine blocks lethal overdose

February 14, 2018
Scientists at The Scripps Research Institute (TSRI) have achieved a major milestone toward designing a safe and effective vaccine to both treat heroin addiction and block lethal overdose of the drug. Their research, published ...

Study shows NIH spent >$100 billion on basic science for new medicines

February 12, 2018
Federally funded research contributed to the science underlying all new medicines approved by the FDA over the past six years, according to a new study by Bentley University.

Opioid use increases risk of serious infections

February 12, 2018
Opioid users have a significantly increased risk of infections severe enough to require treatment at the hospital, such as pneumonia and meningitis, as compared to people who don't use opioids.

Placebo pills prescribed honestly help cancer survivors manage symptoms

February 9, 2018
Long after cancer treatment ends, many continue to deal with one particular symptom that refuses to go away: fatigue. In a new study, researchers at the University of Alabama at Birmingham and Harvard Medical School have ...

Multinational companies continue to produce unregulated antibiotics in India

February 5, 2018
Millions of unapproved antibiotics are being sold in India, according to a new study by researchers at Queen Mary University of London and Newcastle University.

0 comments

Please sign in to add a comment. Registration is free, and takes less than a minute. Read more

Click here to reset your password.
Sign in to get notified via email when new comments are made.