Bagsværd, Denmark, 10 February 2013 – Novo Nordisk today announced that on 8 February 2013 it received a Complete Response Letter from the US Food and Drug Administration (FDA) regarding the New Drug Applicationsfor Tresiba® (insulin degludec) and Ryzodeg® (insulin degludec/insulin aspart). A Complete Response Letter is issued by the FDA, when the agency determines that an application cannot be approved in its current form.
In the letter, the FDA requests additional cardiovascular data from a dedicated cardiovascular outcomes trial before the review of the New Drug Applications can be completed. Novo Nordisk is evaluating the content of the Complete Response Letter and will work closely with the FDA to provide the requested data. Novo Nordisk does not expect to be able to provide the requested data during 2013.
In the letter, the FDA also states that approvals for Tresiba® and Ryzodeg® cannot be granted until the violations cited in the previously announced Warning Letter, dated 12 December 2012, have been resolved.
“We are convinced that Tresiba® and Ryzodeg® offer significant benefits for people who require insulin”, said Lars Rebien Sørensen, chief executive officer of Novo Nordisk. “We are surprised and disappointed to receive this letter, but we acknowledge this decision by the FDA and will work with the agency to determine the best path forward to completing the review.”
Its approved in europe and japan and other parts of asia and why not the USA i wounder.FDA what a joke.
At least part of this is a reaction to manufacturing violations cited in the 12/12/12 letter.
And in defense of the FDA, which has acted as a "tool" of the pharma industry for years, this is perhaps a good and prudent step they have taken to protect patients. All too often we have seen drugs approved without sufficient safety data. Vioxx, Avandia. I don't think I need to say more. But in this case, a meta analysis of 16 pooled studies seemed to show an elevated cardiovascular risk. The risk was increased 32% and could be as high as 93%. Given the limited patient years in the population, these figures do not have great confidence, but it is enough concern that the FDA is taking a good step to assure the safety of this product.
Europe and JP have already been through this with it.Tresiba is just another proudct where FDA gives Eli Lilly time play catch up with NOVO as its so far behind in its late stage devlopment with LY2605541 thats sill in phase2 trials.
I guess my view is that Tresiba (degludec) is really about Novo Nordisk competing against Lantus. Lilly does not have a basal analog insulin yet. And Tresiba is claimed to have a duration of action of 42 hours. Not 48 hours. It is unlikely you could take it every other day and have an even basal profile. It will have be taken every day, just like Lantus. I'm not clear how much of a win this is for NovoNordisk, if this product proves effective, it will cannibalize Levemir and will only be a win if it is better than Lantus. And I've not seen anything yet to suggest it has a big advantage.
As i said Lilly are working on one and Tresiba does work very well in fact as i no D in japan who use it and do inject it once every other day ,As to my sister partner he has been on it some months in the UK,I take it that your knowledge of Tresiba is limited and it has proved a great advantage for those who use it,I work in the pharma and we supply compounds for its use and i have been reading and following its reaserch as it part of my job and it does and in fact can work beyound 42 hours i dont no where you got 48 hours from in first place.
I obtained my information from NovoNordisk which in their press release clearly lists a duration of action of 42 hours and that Tresiba "successfully achieving equivalent reductions in HbA1c" as Lantus (glargine). To me that reads that it works as well as Lantus in lowering A1c. I've never said the insulin didn't work or that some people might not find it has advantages. But if it kinda works beyond 42 hours, that doesn't make it a once every two day insulin.
My endo reported that the trials with T2 patients and Threshiba went very well. I have now used NPH, Levemir and Lantus. Every time I have seen big to small improvements. Perhaps Threshiba will be the next step for me.
This is how you establish a protective tariff without going to the bother of enacting a law.
Holger What is so wonderful about is better control with hypoglycemia in both T1 and T2 and those who suffer with acute forms of nocturnal hypoglycemia,Also what was found even after 4 days that there still some presence in the system of Insulin degludec and is far superior to Insulin glargine or insulin detemir,