Novo resubmits FDA application for two diabetes drugs
pharmafile | March 27, 2015 | News story | Sales and Marketing | Danish, FDA, Novo Nordisk, Ryzodeg, Tresiba, diabetes
Novo Nordisk will re-submit an FDA application for its diabetes drugs Tresiba and Ryzodeg two years after their initial rejection and subsequent police probe into violation claims.
The Denmark-based pharma firm will handover interim analysis of its clinical trials as part of a Class II Resubmission process to the US regulators.
It will comprise of a safety update which will include data from all studies with Tresiba (insulin degludec) as well as an overview of post-marketing data.
The diabetes drugs were rejected by the FDA in February 2013, just weeks after they were approved for use in Europe because more trial data was needed. The regulator requested additional cardiovascular data from a dedicated cardiovascular outcomes trial.
Less than a year later the company faced an investigation from Danish police over delaying the release of the negative information of the drugs. Novo was accused of violating Section 27 (1) of the Danish Securities Trading Act, legislation which imposes a duty to disclose inside information as soon as possible.
The firm was faulted for waiting two days to publish the FDA’s decision, according to the Danish Financial Supervisory Authority who raised the concerns, Novo should have issued a company announcement sooner.
Tresiba is the first insulin approved in Europe at a higher strength than the EU-wide standard of 100 units/ml, whereas Ryzodeg (insulin degludec/insulin aspart) is once or twice-daily administered new-generation soluble formulation.
Both help control the blood sugar level of those with diabetes which according to Diabetes UK, is an illness that affects more than 3.2 million people in the UK with an estimated 630,000 people unaware that they have the condition.
Novo is the world’s largest producer of insulin, and in 2014 announced plans to invest $130 million in new diabetes laboratories at its R&D campus in Denmark.
The company said at the time that the move looks to focus more strongly on the disease area which in 2012 gave Novo sales of $10.9 billion, up 21% year-on-year.
The resubmission for diabetes drugs’ Tresiba and Ryzodeg is expected to take place within the next month.
Tom Robinson
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