MedWatch

Novo: All doubts have been erased

Novo Nordisk believes that concerns over an increased risk of pancreatic cancer from use of GLP-1 analogues have been cancelled out, after the European medicines agency has been unable to show a clear connection – but the authorities are less certain.

Foto: DAGØ JAN

European health agency, EMA, has discovered no increased risk of serious side effects from use of GLP-1 based diabetes drugs, such as Novo Nordisk’s blockbuster Victoza.

The verdict is naturally a great relief to Novo Nordisk, as the company has been debated heavily in the news and medical circles recently, where serious doubts about the safety of the GLP-1 drugs have been raised.

Has all doubts been erased now concerning the increased risk of pancreatic cancer?

“Based on the currently available data there is nothing to suggest an increased risk. Those are the data EMA based their conclusion on. So on the available basis: yes,” Mike Rulis, Head of Communications in Novo Nordisk, tells Medwatch.

But aren’t there still issues that need to be cleared up concerning the risks?

“No. But you could say that the more years that pass the more data we will have. Long term studies are being conducted – including our own major study – which will provide even more certainty once the data are known in three years time.”

No final conclusions

In EMA’s report on the matter, however, the agency says no final conclusions can be drawn and that more studies are under way.

“With regard to pancreatic cancer, data from clinical trials do not indicate an increased risk with these medicines. However, the number of events is too small to draw final conclusions. Due to their mechanism of action (stimulation of beta-cell- and suppression of alpha cell-function) some uncertainties remain in respect to the long-term effect of these medicines on the pancreas and more data collection efforts are under way,” EMA writes.

In Europe the examined products in the drug class include: Victoza (Novo Nordisk), Byetta and Bydureon (Bristol-Myers Squibb), Lyxumia (Sanofi and Zealand Pharma), Januvia and Janumet (Merck), Tradjenta (Boehringer Ingelheim) and Galvus (Novartis).

The full press release from the EMA can be found here.

- translated by Martin Havtorn Petersen

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