US FDA declines to approve AbbVie’s Parkinson’s disease therapy

March 22 (Reuters) – AbbVie Inc (ABBV.N) said on Wednesday the U.S. Food and Drug Administration had declined to approve its Parkinson’s disease therapy for adults.

The U.S. health regulator has sought additional information about the delivery pump, which is part of the marketing application, the drugmaker said, and does not want additional efficacy and safety trials.

Abbvie said it plans to resubmit the marketing application as soon as possible.

Parkinson’s disease is a neurological disease that causes unintended or uncontrollable movements, such as shaking, stiffness, and difficulty with balance and coordination.

Reporting by Khushi Mandowara in Bengaluru; Editing by Shinjini Ganguli and Sriraj Kalluvila

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Source: Reuters