FDA rejects Novo diabetes drugs
pharmafile | February 12, 2013 | News story | Sales and Marketing | FDA, Novo Nordisk, Ryzodeg, Tresiba
The FDA has knocked back two of Novo Nordisk’s diabetes drugs – just weeks after they were approved for use in Europe – saying it wants more trial data.
The US regulator has issued a Complete Response Letter to the Danish firm demanding more information on Tresiba (insulin degludec) and Ryzodeg (insulin degludec/insulin aspart).
It also points out that problems relating to an inspection of an aseptic filling facility in Denmark, which were the subject of a separate warning sent to Novo in December, have not been resolved.
“We are surprised and disappointed to receive this letter,” said Novo chief executive Lars Rebien Sørensen. “We are convinced that Tresiba and Ryzodeg offer significant benefits for people who require insulin,” he went on, pledging to work with the FDA “to determine the best path forward”.
The two drugs sailed through the EU authorisation process and were both given the green light by the European Commission last month. But the FDA wants additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the drugs can be completed.
This is undoubtedly a setback for Novo, which says it will ‘work closely’ with the FDA but states it does not expect to be able to provide the information required this year. The manufacturer says the delay “is not expected to significantly impact” its financial results for 2013 but it is an unwelcome bump in the road.
Novo’s diabetes franchise had sales of $10.9 billion in 2012, up 21% year-on-year, putting the company in a strong position against rivals such as Sanofi – but there is little room for complacency in this popular therapy area.
Tresiba is the first insulin approved in Europe at a higher strength than the EU-wide standard of 100 units/ml, which is significant because patients increasingly require insulin in higher doses to achieve glycaemic control.
Analysts say it could make more than $3 billion a year.
Ryzodeg contains the new-generation basal insulin degludec with a bolus boost of insulin aspart in a soluble formulation which can be administered once or twice-daily with meals.
In studies comparing it to Novo’s own insulin NovoMix, Ryzodeg demonstrated a significantly lower risk of overall and nocturnal hypoglycaemia while achieving the same reductions in HbA1c.
There are now thought to be 250 million diabetes sufferers in the world, a figure that could rise to 380 million by 2025.
Adam Hill
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