Plus   Neg

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 RTTNews Staff Writer

For comments and feedback: editorial@rttnews.com

Business News

Editors Pick
Member of Congress have reportedly been told President Donald Trump's administration has reached an agreement to put Chinese telecom giant ZTE Corp. back in business. Reports from the New York Times and Reuters said the deal brokered by the Commerce Department would require ZTE to pay a substantial... Delta Air Lines will resume non-stop flights between the U.S. and India next year, almost a decade after it exited the Indian market. The airline said Thursday that its decision to resume non-stop flights from the U.S. to India follows agreements between the U.S. and the governments of the United Arab Emirates and Qatar to address the issue of government subsidies provided to state-owned carriers. Mortgage rates continued their upward trend this week and hit a seven-year high, even as housing demand remained robust. According to data released Thursday by mortgage finance provider Freddie Mac, the 30-year fixed-rate mortgage rose to 4.66 percent in the week ending May 24, from 4.61 percent in the prior week and 3.95 percent a year ago. This is also the highest level since May 5, 2011.
Follow RTT