Regulatory Affairs

Novartis wins FDA approval for new dosage strength of Exelon Patch

PBR Staff Writer Published 04 September 2012

Novartis has obtained the US Food and Drug Administration (FDA) approval for a new 13.3 mg/24 h dosage strength of its Exelon Patch (rivastigmine transdermal system), designed to treat patients with mild to moderate Alzheimer's disease.

The approval is based on efficacy and safety data demonstrated in a 48-week double-blind phase of the OPTIMA study, which compared13.3 mg/24 h to 9.5 mg/24 h in declining mild to moderate Alzheimer's patients.

The trial met a co-primary endpoint showing statistically significant (p<0.05) improvement in patients overall function compared to the 9.5 mg/24 h patch, as measured by the instrumental activities of daily living scale (ADCS-IADL) at week 48.

Improvement in cognition (measured by ADAS-Cog) compared to the lower dose was statistically significant at 24 weeks but not at 48 weeks (also a co-primary endpoint).

Brain Health Cleveland Clinic Lou Ruvo Center director Jeffrey Cummings said, "Alzheimer's disease is marked by progressive symptomatic decline, resulting in an increasingly large physical and emotional challenge for the patient and caregiver."

National Family Caregivers Association chief executive officer John Schall said, "From the caregiver's standpoint, a patch can be visual evidence to help see if their loved one has actually received their medication, so to have an additional option is important."

Novartis Pharmaceuticals president Andre Wyss said, "We believe in transdermal application and the efficacy of Exelon Patch, and we are committed to continuing our research in Alzheimer's disease."

In addition to Alzheimer's disease, Exelon Patch can be used to treat mild to moderate dementia associated with Parkinson's disease.