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news.Shire Pharmaceuticals has suffered a 4% share drop after its Johnson and Johnson co-developed Alzheimer's treatment, Reminyl, raised regulators' concerns in a safety assessment.
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Johnson & Johnson Pharmaceutical R&D (J&JPRD)announced that health authorities are reviewing scientific data from two clinical trials evaluating an investigational use of Reminyl (galantamine hydrobromide) in individuals with mild cognitive impairment.
The review was initiated as a result of a preliminary safety assessment of two mild cognitive impairment clinical trials submitted to health authorities in August 2004, in which more patients taking Reminyl died than those given placebo.
In the studies, 20 deaths due to various causes were reported during the double-blind portion of the two pivotal studies, with 15 occurring in subjects randomized to galantamine and five occurring in patients receiving placebo.
Approximately 2,000 patients from 16 countries were enrolled in the GAL-INT-11 and GAL-INT-18 studies, which were designed to evaluate a potential decrease in the rate of progression from mild cognitive impairment to dementia in subjects treated with the drug.
J&JPRD is currently analyzing additional data from these studies, including information retrieved from subjects who had dropped out of the trials, and is discussing the results with regulatory authorities.
J&JPRD developed Reminyl under a co-development and licensing agreement with UK-based Shire Pharmaceuticals Group. Janssen Pharmaceutica Products manufactures and markets the product in the US.
Reminyl is approved to treat patients with mild to moderate dementia of Alzheimer’s. No regulatory applications have been submitted for the potential use of Reminyl for the treatment of mild cognitive impairment anywhere in the world, nor are any planned.