FDA approves Novartis brain tumour drug

Oct 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.

Explore further: Determine patient preferences by means of conjoint analysis

add to favorites email to friend print save as pdf

Related Stories

Novartis denies problems with swine flu vaccine

Oct 26, 2009

Swiss pharmaceutical group Novartis on Monday denied that it faced hurdles in gaining regulatory approval in Switzerland for one of its swine flu vaccines because of possible bacterial contamination.

Novartis gains FDA approval for new MS drug

Sep 22, 2010

(AP) -- Federal health regulators have approved the first pill to treat the underlying causes of multiple sclerosis, a debilitating nervous system disorder that has traditionally been treated with injectable drugs.

FDA approves skin cancer drug

Oct 13, 2006

The U.S. Food and Drug Administration approved a new drug to treat a rare, slow-growing skin cancer.

Recommended for you

Determine patient preferences by means of conjoint analysis

Jul 29, 2014

The Conjoint Analysis (CA) method is in principle suitable to find out which preferences patients have regarding treatment goals. However, to widely use it in health economic evaluations, some (primarily methodological) issues ...

FDA approves hard-to-abuse narcotic painkiller

Jul 25, 2014

(HealthDay)—A new formulation of a powerful narcotic painkiller that discourages potential abusers from snorting or injecting the drug has been approved by the U.S. Food and Drug Administration.

Race affects opioid selection for cancer pain

Jul 25, 2014

(HealthDay)—Racial disparities exist in the type of opioid prescribed for cancer pain, according to a study published online July 21 in the Journal of Clinical Oncology.

FDA approves tough-to-abuse formulation of oxycodone

Jul 25, 2014

(HealthDay)—Targiniq ER (oxycodone hydrochloride and naloxone hydrochloride extended release) has been approved by the U.S. Food and Drug Administration as a long-term, around-the-clock treatment for severe ...

User comments : 0