LONDON (Reuters) – Benlysta (belimumab), a new drug for lupus from GlaxoSmithKline and Human Genome Sciences, has been rejected by Germany’s healthcare cost watchdog in a decision that adds to the product’s uphill battle in Europe.
The negative draft benefit assessment from the German Institute for Quality and Efficiency in Health Care (IQWiG) follows a similar rebuff from Britain’s National Institute for Health and Clinical Excellence (NICE).
The drug, which was discovered by Human Genome and developed with GSK to combat lupus, is at the centre of a $2.6 billion takeover bid by GSK for its U.S. biotech partner.
GSK, Britain’s biggest drugmaker, said on Thursday that the judgment from IQWiG was “completely inexplicable from a medical point of view and disregards genuine progress in therapy.”
Benlysta, the first new treatment for lupus in a half-century, was approved in Europe last July, following a U.S. green light in March 2011.
Existing treatments for lupus include steroids and immunosuppressant drugs, which can have serious side effects and do not always work for lupus patients.