UPDATE 1-Novo sees no rise in pancreatitis from liraglutide

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By Karin Jensen

COPENHAGEN Aug 19 (Reuters) - Denmark's Novo Nordisk (NOVOb.CO) said it has seen no evidence of a statistically significant increase in cases of pancreas inflammation in trials of drug candidate liraglutide.

The U.S. Food and Drug Administration warned on Monday of more cases of dangerous pancreas inflammation in patients taking Amylin Pharmaceuticals Inc's AMLN.O diabetes drug, Byetta, a drug that is expected to compete with liraglutide [ID:nN18460095].

Novo Nordisk Chief Science Officer Mads Krogsgaard Thomsen told Reuters on Tuesday that although there had been cases of pancreatitis in patients treated with liraglutide, Novo had "not seen a statistically significant increased frequency" in patients treated with the drug.

Thomsen noted that although U.S. health regulators had received six reports of haemorrhagic or necrotizing pancreatitis requiring hospitalisation, including two deaths, in Byetta users, this was out of half a million users.

"This gives an extremely low frequency ... it is of course always nasty when people die because of side effects but as a frequency it is extremely low compared to what we see in other drug classes," he said.

Shares in Novo Nordisk were down 3.5 percent at 1055 GMT on Tuesday while Amylin's shares closed 13 percent down in U.S. trade on Monday.

Both drugs are part of a class known as incretin mimetics designed to induce the same effects as a blood sugar-improving hormone called GLP-1.

LABLE WARNING LIKELY

"It's simply so that pancreatitis in diabetics is something that occurs with a higher frequency," Thomsen said.

The FDA said it was working to add stronger, more prominent warnings in the product label with Amylin, which co-markets Byetta with Eli Lilly and Co (LLY.N).

Thomsen said it was likely that after U.S. approval, expected in March next year, the FDA would require a similar warning on liraglutide's label, but that the warning would probably cover all GLP-1 class diabetes drugs.

"The important thing is that it's a very unusual side effect and that the warning, if there is one, is of the same type as we see on most diabetes drugs," he said.

Thomsen said that even if GLP-1 drugs do carry these infrequent side effects, the benefits of the class far outweigh the risks.

GLP-1 class drugs stimulate the release of insulin only when glucose levels become too high. They also lead to modest weight loss, which is seen as an advantage over other types of diabetes medicines, because obesity is a leading cause of the disease.

(Reporting by Karin Jensen; Editing by Rory Channing and Erica Billingham)