EU regulator finds no new safety issues with diabetes drugs
LONDON, July 26
LONDON, July 26 (Reuters) - European drugs regulators have found no new safety concerns with diabetes drugs known as GLP-1 and DPP-4 therapies after concluding a safety review of possible links to damage to the pancreas.
The class of drugs - known as glucagon-like-peptide-1 (GLP-1) agonists and dipeptidylpeptidase-4 (DPP-4) inhibitors - includes Merck's $4 billion-a-year Januvia franchise, Novo Nordisk's Victoza, and Byetta and Onglyza from Bristol-Myers Squibb and AstraZeneca, among others.
The European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use reviewed the medicines after a study suggested they may increase the risk of pancreatitis, or inflammation of the pancreas, and cellular changes called pancreatic-duct metaplasia in patients with type 2 diabetes.
The U.S. Food and Drug Administration (FDA) said in March it was also studying the drugs' safety.
But the EMA said on Friday said that after a review of all available non-clinical and clinical data, "there is no change in evidence regarding the risks of pancreatic adverse events".
The EMA said its experts had reviewed the study itself and found "a number of methodological limitations and potential sources of bias" which it said "preclude a meaningful interpretation of the results".
More than 370 million people are living with diabetes worldwide, with type 2 accounting for 90 percent to 95 percent of the cases, according to the International Diabetes Federation.
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