AbbVie Inc said the FDA had declined to approve its Parkinson's disease therapy for adults and had requested for more information on the device used to administer the treatment.
- AbbVie Inc said on Wednesday the U.S. Food and Drug Administration had declined to approve its Parkinson's disease therapy for adults and had requested for more information on the device used to administer the treatment.
The company's application was based on data that showed the therapy significantly extended the time that patients did not observe involuntary movement, compared to orally administered carbidopa-levodopa. The U.S. health regulator has not sought additional efficacy and safety trials, the company said, adding it plans to resubmit the marketing application as soon as possible.
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