After a first early benefit assessment in April 2012, the German Institute for Quality and Efficiency in Health Care (IQWiG) has now re-examined whether Nulojix (belatacept) offers an added benefit over the appropriate comparator therapy. This new assessment was conducted because a limitation of the corresponding decision by the Federal Joint Commission (G-BA) expired in July 2015.
US pharma major Bristol-Myers Squibb’s (NYSE: MBY) Nulojix has been approved in Europe since June 2011 for adults after a kidney transplant. It is used together with other drugs to prevent the body from rejecting the transplanted organ.
An indication of considerable added benefit in comparison with ciclosporin A can be derived from the second dossier, the IQWiG stated. Renal insufficiency due to rejection reactions occurs less frequently under belatacept – and this is the case in all transplanted patients. The first dossier, in contrast, had shown an indication of minor added benefit only in a certain type of donors.
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