Biogen, Swedish Orphan Biovitrum sales and marketing update

Germany’s Institute for Quality and Efficiency in Health Care (IQWiG) said in a dossier assessment that an added benefit was not proven for Elocta efmoroctocog alfa vs. comparator therapies to prevent and treat hemophilia A. The agency said Swedish Orphan’s dossier did not include data for a direct comparison to a recombinant or human-derived coagulation Factor VIII drug and said the data provided were inadequate. IQWiG also said the data were incomplete, noting that Swedish Orphan excluded patients under 12 years of age as well as human plasma preparations and that the company only considered the number of annual bleeding events and the use of Factor VIII preparations. ...