Selincro nalmefene regulatory update

The U.K.’s NICE issued final guidance recommending the use of Selincro nalmefene from H. Lundbeck to reduce alcohol consumption in adults with alcohol dependence who have a high drinking risk level without physical withdrawal symptoms and who do not require immediate detoxification -- its approved indication in the EU. The final guidance is in line with a final appraisal determination (FAD) issued in October (see BioCentury, Oct. 13).

Separately, Germany’s Institute for Quality and Efficiency in Healthcare (IQWiG) said in an early benefit assessment that the added benefit of Selincro was not proven. IQWiG said the manufacturer only provided for an indirect comparison with the appropriate comparator therapy, naltrexone, but the agency considered the data “unsuitable.” ...