FDA reviewing possible Stalevo-prostate cancer link

The FDA says it is evaluating clinical trial data that suggests that patients taking Stalevo, Novartis and Orion's Parkinson's disease treatment, may be at an increased risk for developing prostate cancer. The agency emphasizes its review of Stalevo is ongoing and no new conclusions or recommendations about the use of this drug have been made.

Although Orion shares went 10.9 percent lower on the news to €14.58, analysts downplayed the announcement. "The study results were already communicated a year ago, and now the FDA is looking further into it," says analyst Sami Sarkamies at Nordea Markets, as quoted by Reuters. "If it was a new drug with a ten-year patent, possibly the impact would be bigger, but this is a drug living the last moments of its life cycle," he adds.

The data under review are from a long-term clinical trial called Stalevo Reduction in Dyskinesia Evaluation-Parkinson's Disease (STRIDE-PD). The trial evaluated the time to onset of dyskinesia in patients with Parkinson's disease taking Stalevo compared with those taking Sinemet (carbidopa/levodopa). An unexpected finding in the trial was that a greater number of patients taking Stalevo were observed to have prostate cancer compared with those taking Sinemet.

Previous controlled clinical trials of shorter duration evaluating Stalevo in Parkinson's disease have not found an increased risk of prostate cancer, and prostate cancer is most commonly diagnosed in men who are of the same age as men included in the STRIDE-PD trial.

In a statement, Orion says it has not further details to add to the already published information concerning Stalevo and the results of the STRIDE-PD study. But Orion Chief Executive Timo Lappalainen is quoted by Reuters as saying, "We have not seen this is as such a significant matter that we would need to communicate it." He adds that he doesn't expect sales to be affected. Lappalainen said Orion had delivered its database on Stalevo to the FDA "some time ago" when the firm was planning to broaden the use of the drug.

- read Orion's release
- check out the FDA's statement
- see the Reuters coverage

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