Novo Nordisk (NVO) recently presented new data on its type II diabetes drug, Tresiba (degludec), from a one-year extension study, BEGIN ONCE LONG.
Data from the study was presented at the 73rd Scientific Sessions of the American Diabetes Association (:ADA). The parallel-group, randomized, open-label, treat-to-target study compared Tresiba versus Sanofi’s (SNY) Lantus.
Data from the study revealed statistically significant improvement in the health-related quality of life in patients treated with Tresiba compared to those treated with Lantus. Moreover, patients treated with Tresiba showed significantly lower rates of nocturnal confirmed hypoglycemia as compared with those receiving Lantus.
The BEGIN ONCE LONG study recorded higher overall physical component score from patients receiving Tresiba versus Lantus after two years. Patients on Tresiba also showed significantly better physical functioning as well as better scores on body pain.
In 2010, Novo Nordisk completed the phase IIIa BEGIN program. The two programs -- BEGIN and BOOST -- included 17 randomized, controlled, treat-to-target trials. The data from these studies formed the basis of the regulatory applications for Tresiba and Ryzodeg.
Tresiba is already approved in the EU (Jan 2013) and Japan (2012). We note that, Novo Nordisk suffered a setback when the US Food and Drug Administration (:FDA) declined to approve Tresiba on the basis of submitted data and issued a complete response letter (CRL) on Feb 10, 2013.
The setback is all the more shocking since in Nov 2012, Tresiba had received a positive opinion from the FDA’s Advisory Committee. The FDA, while issuing the CRL, asked Novo Nordisk to conduct a dedicated cardiovascular outcomes study and provide additional cardiovascular data.
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