Monday, September 3, 2012

Prostate Cancer Drug Approved by FDA - Health Aim

A prostate cancer medication that has been developed by Astellas Pharma and Medivation Inc, was approved by the Food and Drug Administration. The drug was approved for use by men whose prostate cancer has spread despite being treated with chemotherapy and hormone therapy.

The approval of the medication that will be sold as Xtandi, comes three months prior to the agency’s decision deadline for the product that was scheduled for late in November. The news from the agency sent Medivation stock prices up nearly 8%.

Analysts on Wall Street forecasted that the sales by Medivation of the new drug would reach $1.2 billion in 2017. Xtandi is in a category of new drugs referred to as androgen inhibitors. It is designed to interfere with testosterone’s ability to bind cells of prostate cancer. The male hormone fuels the cell growth of prostate cancer.

The drug will start being sold, said Medivation, in the U.S. during September and will carry a wholesale price of $7,450 for a supply that will last 30 days. The drug, during trials, was used for an average of eight months, said the company.

Both Astellas and Medivation have also filed for approval of the drug in Europe. Last November the two pharmaceutical companies reported that an important study of Xtandi was stopped early when it revealed that the medication improved the survival rate overall by nearly 5 months compared to just a placebo.

There are tests taking place now with the medication for men with an earlier stage prostate cancer however, Medivation did not say when they expected test results from the studies to be available.

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