) recently presented new data on its type II diabetes drug,
Tresiba (degludec), from a one-year extension study, BEGIN ONCE
Data from the study was presented at the 73
Scientific Sessions of the American Diabetes Association (ADA).
The parallel-group, randomized, open-label, treat-to-target study
compared Tresiba versus
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
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
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.
Novo Nordisk currently carries a Zacks Rank #2 (Buy).
Currently, companies like
Jazz Pharmaceuticals plc
) look more attractive with a Zacks Rank #1 (Strong Buy).
JAZZ PHARMACEUT (JAZZ): Free Stock Analysis
NOVO-NORDISK AS (NVO): Free Stock Analysis
SANTARUS INC (SNTS): Free Stock Analysis
SANOFI-AVENTIS (SNY): Free Stock Analysis
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