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Novartis Says FDA Okays Higher Dose Of Exelon Patch For Alzheimer's

Swiss drug giant Novartis AG (NVS) Tuesday said that the US Food and Drug Administration approved a higher dose of Exelon Patch, or rivastigmine transdermal system, for the treatment of people with mild to moderate Alzheimer's disease.

According to Novartis, the new 13.3 mg/24 h dosage strength of Exelon Patch provides physicians with a new treatment option for patients who are experiencing a decline in overall function and cognition.

Approval of the patch was based on the 48-week double-blind phase of the OPTIMA study in mild to moderate AD patients who met the pre-defined criteria for functional and cognitive decline on the 9.5mg/24 h dose.

Patients treated with the 13.3 mg/24 h patch experienced statistically significant improvement in their overall function compared to the 9.5 mg/24 h patch as measured by the instrumental activities of daily living scale at week 48 which was a co-primary endpoint.

Improvement in cognition compared to the lower dose was nominally statistically significant at 24 weeks but not at 48 weeks.

During the 48-week dose-comparison phase of OPTIMA, no unexpected adverse events leading to discontinuation were reported. The safety profile of the higher dose was consistent with that of the currently approved doses of Exelon Patch.

Overall, the percentage of patients with adverse events leading to discontinuation was lower in the 13.3 mg/24 h group compared to the 9.5 mg/24 h group.

Jeffrey Cummings, Director of the Cleveland Clinic Lou Ruvo Center for Brain Health, said, ''Alzheimer's disease is marked by progressive symptomatic decline, resulting in an increasingly large physical and emotional challenge for the patient and caregiver. Having multiple options for the treatment of mild to moderate Alzheimer's disease will help physicians better care for patients with the hope of improving function and cognition."

The stock rose 0.4 percent in Zurich to settle at 56.50 euros on Monday.

NVS closed up 0.4 percent at $59.01 on the NYSE.

by RTT Staff Writer

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