BAGSVAERD, Denmark I June 13, 2013 I Today, Novo Nordisk presented data further supporting the safety of Victoza (liraglutide [rDNA origin] injection) at a scientific workshop in the US arranged by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Cancer Institute (NCI).At the two-day workshop, regulators, academic and scientific experts as well as representatives from the pharmaceutical industry came together to discuss suspected mechanisms linking pancreatitis, diabetes and pancreatic cancer.
At the workshop, Solomon Iyasu, MD, director of the division of Epidemiology, U.S. Food and Drug Administration (FDA), presented the FDA’s approach to address and assess pancreatic safety of the incretin mimetic class of diabetes drugs (GLP-1 receptor agonists and DPP-IV inhibitors). In Dr Iyasu’s presentation, the FDA stated that review of epidemiological studies submitted to the FDA and published in journals has provided conflicting results and does not provide reliable evidence to refute or support a causal link between incretin mimetics and the risk of acute pancreatitis. Consequently, FDA concluded that an evaluation of a potential association between incretin mimetics and pancreatitis and pancreatic cancer would require adequately powered long-term epidemiological studies.
At the workshop, Novo Nordisk presented interim data from an ongoing prospective, matched cohort epidemiological study comparing Victoza® with four other widely used anti-diabetic drug classes in each cohort. The study comprised more than 100,000 patient years of treatment, with between 14,000 and 19,000 patients on Victoza® and comparator treatment in each cohort. The observed relative risks of both pancreatitis and pancreatic cancer for Victoza® were similar to, or numerically lower than, that of the comparators in each cohort, as previously communicated. The results of the study were presented as part of a complete overview of available Victoza® safety data, including non-clinical and clinical data as well as data from post-marketing commitments that together reconfirmed the safety profile of Victoza®.
“We remain very confident in the safety profile of Victoza®, which has been extensively studied throughout the development and marketing phases”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Our confidence in the positive benefit-risk profile of Victoza® is reassured by the interim data from the prospective epidemiological study presented today”.
Novo Nordisk is dedicated to the continued monitoring and reporting on the safety profile of Victoza® and will work with health authorities, scientific experts, diabetes associations and other stakeholders to ensure that patients and physicians have a clear understanding of the benefit-risk profile of the product.
SOURCE: Novo Nordisk
Post Views: 221
BAGSVAERD, Denmark I June 13, 2013 I Today, Novo Nordisk presented data further supporting the safety of Victoza (liraglutide [rDNA origin] injection) at a scientific workshop in the US arranged by the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) and the National Cancer Institute (NCI).At the two-day workshop, regulators, academic and scientific experts as well as representatives from the pharmaceutical industry came together to discuss suspected mechanisms linking pancreatitis, diabetes and pancreatic cancer.
At the workshop, Solomon Iyasu, MD, director of the division of Epidemiology, U.S. Food and Drug Administration (FDA), presented the FDA’s approach to address and assess pancreatic safety of the incretin mimetic class of diabetes drugs (GLP-1 receptor agonists and DPP-IV inhibitors). In Dr Iyasu’s presentation, the FDA stated that review of epidemiological studies submitted to the FDA and published in journals has provided conflicting results and does not provide reliable evidence to refute or support a causal link between incretin mimetics and the risk of acute pancreatitis. Consequently, FDA concluded that an evaluation of a potential association between incretin mimetics and pancreatitis and pancreatic cancer would require adequately powered long-term epidemiological studies.
At the workshop, Novo Nordisk presented interim data from an ongoing prospective, matched cohort epidemiological study comparing Victoza® with four other widely used anti-diabetic drug classes in each cohort. The study comprised more than 100,000 patient years of treatment, with between 14,000 and 19,000 patients on Victoza® and comparator treatment in each cohort. The observed relative risks of both pancreatitis and pancreatic cancer for Victoza® were similar to, or numerically lower than, that of the comparators in each cohort, as previously communicated. The results of the study were presented as part of a complete overview of available Victoza® safety data, including non-clinical and clinical data as well as data from post-marketing commitments that together reconfirmed the safety profile of Victoza®.
“We remain very confident in the safety profile of Victoza®, which has been extensively studied throughout the development and marketing phases”, said Mads Krogsgaard Thomsen, executive vice president and chief science officer of Novo Nordisk. “Our confidence in the positive benefit-risk profile of Victoza® is reassured by the interim data from the prospective epidemiological study presented today”.
Novo Nordisk is dedicated to the continued monitoring and reporting on the safety profile of Victoza® and will work with health authorities, scientific experts, diabetes associations and other stakeholders to ensure that patients and physicians have a clear understanding of the benefit-risk profile of the product.
SOURCE: Novo Nordisk
Post Views: 221
