Transparency Issues Floor Novo Nordisk's Tresiba At IQWiG
This article was originally published in The Pink Sheet Daily
IQWiG has said that Novo Nordisk's refusal to make public part of its dossier for its diabetes therapy Tresiba represents a lack of transparency and makes the drug impossible to recommend.
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Europe’s parliamentarians have unsurprisingly and overwhelmingly voted in favor of the Clinical Trials Regulation – but implementation and transparency problems hover on the horizon.
Withholding Tresiba from Europe’s biggest drug market seems counterintuitive in view of the ultra-long-acting insulin’s spreading acceptance elsewhere. But in doing so, Novo avoids having Germany’s reimbursement authorities questioning its benefits and demanding a price cut.
FDA is requesting data from a dedicated cardiovascular outcomes trial before approving the ultra-long-acting insulins Tresiba and Ryzodeg. News of the regulatory setback caused a 13% drop in the company’s stock price on Feb. 11.