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(Medical-NewsWire.com, November 29, 2012 ) San Francisco, CA -- The first human gene therapy drug, known as Glybera, will begin selling in Europe in 2013, the first drug of its type to be made available in Europe or the United States.
Glybera, which will be used to treat lipoprotein lipase deficiency (LPLD), an extremely rare disorder, was approved for sale in Europe on October 25 by the European Commission in a ruling reached at The Hague in the Netherlands.
UniQure, a Dutch-based biotech company, says that they expect to have the drug available for sale by the middle of next year.
In a statement, uniQure's chief executive, Joern Aldag, said, "We believe that after Glybera's approval gene therapy is at the beginning of a period of rapid growth similar to the development of the antibody business in the last decade."
Offering the potential ability to block or even reverse inherited diseases, gene therapy first began to gain prominence in the late 1990s. Gene therapy, which is used to alter a patient's DNA in order to fight disease, has been used experimentally to treat a wide variety of diseases, ranging from blindness to depressions. Some work has been successful on diseases that cause the brain to lose function, such as Alzheimer's diseases.
China was among the first nations to see the value in gene therapy, approving a gene therapy to treat certain head and neck cancers all the way back in 2003. However, getting approval in Europe and the U.S. has been a struggle.
Part of the reason for this is that there have been few documented successful trials, usually limited to single-gene disorders. Most diseases, such as cancer, are made up of complex, multigene disorders.
Glybera will be used to treat LPLD, which is an inherited disease that affects only about one person in two million. The disease prevents those afflicted with LPLD from metabolizing certain fat particles in their bloodstream.
UniQure stated that they are working on a number of additional gene therapies to treat diseases, such as hemophilia B, acute intermittent porphyria, and Parkinson's disease.
As the first commercial sales of Glybera begin next year, uniQure is also continuing to seek approval for the gene therapy in the U.S. as well.
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Source: EmailWire.com
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