Other safety alerts
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| The United States: FDA finds drugs under investigation in the U.S. related to French BIA 10-2474 drug do not pose similar safety risks |
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The U.S. Food and Drug Administration (FDA), with information received from the European Medicines Agency (EMA) and the French national medicines agency (ANSM), has completed a comprehensive review of safety information relevant to the investigational new drug BIA 10-2474 and the potential implications for related drugs under investigation in the U.S. The Agency has found, based on the available information, that BIA 10-2474 exhibits a unique toxicity that does not extend to other drugs in the class, called fatty acid amide hydrolase (FAAH) inhibitors.
There are no clinical trials with BIA 10-2474 underway in the U.S. The first phase 1 clinical trial of BIA 10-2474 was conducted in France in January, 2016, and resulted in the death of one enrolled subject and hospitalization of 5 others. Four of these 5 subjects experienced neurological injury.
Based on these findings, the FDA is working with sponsors to establish the appropriate path forward for FAAH inhibitors under investigation in the U.S. We are also working to ensure healthy subjects, patients, and investigators participating in FAAH inhibitor clinical trials are fully informed of the risks and potential benefits of these experimental therapies.
Please refer to the following website in FDA for details:
http://www.fda.gov/Drugs/DrugSafety/ucm482740.htm
In Hong Kong, a clinical trial certificate is required before conducting a clinical trial on pharmaceutical product. As previously reported, no clinical trial certificate application involving French BIA 10-2474 drug has been received by the Department of Health. Related news was previously issued by the Medicines and Healthcare products Regulatory Agency (MHRA) and FDA, and was posted on the Drug Office website on 18 January and 25 January 2016 respectively.
Ends/ Saturday, August 13, 2016
Issued at HKT 13:00
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