 |
|
|
Teva Pharmaceuticals Industries Ltd. announced on Monday
results of Phase III study, called ADAGIO, involving 1 mg tablets of Azilect
(rasagiline).
The 18-month trial, involving 1,176 patients suffering from
early Parkinson’s disease in 14 countries and 129 medical centers, showed the
drug proved efficient in slowing the progression of Parkinson’s disease.
Parkinson’s disease is a brain disorder, which occurs when
certain nerve cells (neurons) in a part of the brain called the substantia nigra
die or become impaired. In normal conditions, these cells produce a vital
chemical known as dopamine, which allows smooth, coordinated function of the
body’s muscles and movement. The symptoms of Parkinson’s disease (tremor,
slowness in movement, rigidity, and difficulty with balance) generally appears
when approximately 80 percent of the dopamine-producing cells are damaged.
It is estimated that 60,000 new cases are diagnosed each
year in the U.S.,
joining the 1.5 million Americans who currently have the disease. While the
condition usually develops after the age of 65, 15 percent of those diagnosed
are under 50.
The ADAGIO study was designed to demonstrate that Azilect
could slow down the incursion of Parkinson’s disease, which it successfully
accomplished with statistical significance. Therefore, the drug could become
the first Parkinson’s disease treatment to receive a label for disease-modification,
Teva said in a statement, according to Reuters.
The statement also read that the positive results “could
dramatically increase the market potential for Azilect,” which had first-quarter
sales of $37.5 million, up 50 percent.
Now the company intends to forward the trial’s results to U.S. and
European regulatory authorities.
© 2007 - 2008 - eFluxMedia