|Pfizer's Bosutinib Wins Positive Opinion for CMA from CHMP; Lilly's Solanezumab Chosen for Alzheimer's Study|
|By Staff and Wire Reports|
|Friday, 18 January 2013 19:44|
Pfizer Inc. (NYSE: PFE) announced the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the conditional marketing authorization of bosutinib in the European Union (EU) for the treatment of adult patients with chronic phase (CP), accelerated phase (AP), and blast phase (BP) Philadelphia chromosome positive chronic myelogenous leukemia (Ph+ CML) previously treated with one or more tyrosine kinase inhibitor(s) (TKIs) and for whom imatinib, nilotinib and dasatinib are not considered appropriate treatment options.
The positive opinion for bosutinib was based on data from Study 200, a global, single-arm, open-label, multi-cohort, Phase 1/2 study of bosutinib in more than 500 patients with Ph+ CML with separate cohorts for chronic, accelerated and blast phase disease previously treated with one or more prior TKIs.
Conditional approvals in the EU are granted to medicinal products with a positive benefit/risk assessment that address unmet medical needs and whose availability would result in a significant public health benefit.
Researchers have chosen an experimental drug by Eli Lilly & Co. (NYSE:LLY) for a large federally funded study testing whether it's possible to prevent Alzheimer's disease in older people at high risk of developing it.
The drug, called solanezumab, is designed to bind to and help clear the sticky deposits that clog patients' brains. Earlier studies found it did not help people with moderate to severe Alzheimer's but it showed some promise against milder disease. Researchers think it might work better if given before symptoms start. "The hope is we can catch people before they decline," which can come 10 years or more after plaques first show up in the brain, said Dr. Reisa Sperling, director of the Alzheimer's center at Brigham and Women's Hospital in Boston. She will help lead the new study, which will involve 1,000 people ages 70 to 85 whose brain scans show plaque buildup but who do not yet have any symptoms of dementia. They will get monthly infusions of solanezumab or a dummy drug for three years.
The main goal will be slowing the rate of cognitive decline. The study will be done at 50 sites in the U.S. and possibly more in Canada, Australia and Europe, Sperling said. In October, researchers said combined results from two studies of solanezumab suggested it might modestly slow mental decline, especially in patients with mild disease. Taken separately, the studies missed their main goals of significantly slowing the mind-robbing disease or improving activities of daily living. Those results were not considered good enough to win the drug approval.
So in December, Lilly said it would start another large study of it this year to try to confirm the hopeful results seen patients with mild disease. That is separate from the federal study Sperling will head. About 35 million people worldwide have dementia, and Alzheimer's is the most common type. In the U.S., about 5 million have Alzheimer's. Current medicines such as Aricept and Namenda just temporarily ease symptoms. There is no known cure.
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