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Update: Understanding the Recent Announcement about Azilect® and its Potential to Slow the Progression of Parkinson’s Disease

Teva Pharmaceuticals issued an announcement about the results of its Phase III clinical trial, ADAGIO, which tested the neuroprotective abilities of Azilect® (rasagiline), a medication already on the market for the treatment of the signs and symptoms of Parkinson's disease. Teva announced that it had applied to the US Food and Drug Administration (FDA) for approval to market Azilect for its potential to slow the course of the disease.

It was announced today that the data from ADAGIO, which has not yet been released, will be presented at the 12th Congress of European Federation of Neurological Societies (EFNS) on August 26, 2008 in Madrid, Spain.

On June 20, PDF issued a statement about this development, which appears below. To also read one of this week’s earlier news releases about this study, please scroll beneath the statement or click here.

Statement from the Parkinson's Disease Foundation (PDF)
Earlier this week, Teva Pharmaceuticals, the Israel- based company that manufactures Azilect® (rasagiline), an anti-Parkinson’s medication, announced that it has applied to the US Food and Drug Administration (FDA) for approval to market Azilect for its potential to slow the course of the disease.

In 2006, the FDA approved Azilect as a stand- alone treatment for people with early Parkinson’s and as a treatment in conjunction with levodopa for people with more advanced Parkinson's. If the FDA should approve its new request, this would be the first treatment to be marketed in the US for a disease-slowing property.

According to the company’s press release, Teva has new data from a large 18-month study known as ADAGIO that it claims supports a neuroprotective benefit for Azilect. Unfortunately, the data have not yet been released and so the Parkinson’s Disease Foundation (PDF) is not in a position to judge whether the claim is valid and how strong the benefit is, and therefore to what extent people with Parkinson’s and their families should be encouraged by the news.

The value of Azilect as a treatment to ease Parkinson’s symptoms has been well demonstrated over several years of successful use by thousands of patients. Its value as a neuroprotective has been suggested by an earlier, smaller study, but has not been proven. The new study – and the FDA’s response to this – may help to clarify Azilect’s potential in this area but we will not know for sure until the data have been released.

While PDF recognizes that companies are legally obligated to notify the public when they have information that may impact the price of their shares, we also believe that they have the same obligation, albeit a moral rather than a legal one, to extend the same opportunity to the scientists who run the trials and the patients who have the greatest stake in their outcome. We urge the research and regulatory communities to recognize this obligation, and to assure us all that in future, when claims of this kind are made public, that they be accompanied by the scientific data on which these claims are based.

PDF’s Medical Policy Committee will be watching the situation very carefully over the next several weeks – beginning with monitoring the annual meeting of The Movement Disorders Society in Chicago next week, when there may be discussion of the treatment – to review the data and to evaluate its significance. As soon as we have something to report, we will place it on our website, www.pdf.org.

Teva says data demonstrates Azilect slows progression of Parkinson's disease
June 16, 2008: 07:32 AM EST NEW YORK (Associated Press) - Teva Pharmaceutical Industries Ltd. on Monday said trial data from its Parkinson's disease drug Azilect showed it can slow the progression of the disease.

Parkinson's drugs, including Azilect, are approved to treat symptoms of the disease.

The trial, which enrolled 1,176 patients with an early stage form of Parkinson's, met its goal in three areas, including a change in a common measurement used to assess disease status.

The Israeli drug maker said it would submit the data to regulatory authorities in the U.S. and Europe to get Azilect's labeling changed to include disease modification. Teva shares rose $2.04, or nearly 5 percent, to $44.54 in premarket trading.

Source Date: Jun 16 2008
Source Publication: Associated Press
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