November 29, 2016
By Nikolaj Skydsgaard | COPENHAGEN
(Reuters) - Novo Nordisk's long-acting insulin blockbuster Tresiba has a safe cardiovascular profile and reduces episodes of severely low blood glucose levels in patients with type 2 diabetes, the Denmark-based company said on Tuesday.
Type 2 diabetics who need insulin to control their blood sugar risk having too low levels of glucose in their blood, which can cause tiredness, confusion and in some cases unconsciousness.
The so-called DEVOTE study, involving more than 7,500 patients, demonstrated Tresiba's non-inferiority of major adverse cardiovascular events to rival Sanofi's long-acting insulin Lantus (insulin glargine), Novo said.
Interim data from DEVOTE ensured the U.S. Food & Drug Administration's (FDA) approval of Tresiba in September 2015, so either neutral or positive results were to be expected from Tuesday's announcement.
However, data from the study has been kept under wraps until now in order not to impact the remaining study results.
Tresiba, a once-daily basal insulin which keeps a diabetic's blood glucose levels stable between meals and during sleep, also showed a statistically significant 40 percent overall reduction of severe hypoglycaemia in patients.
Patients treated with Tresiba also experienced a 54 percent lower rate of nocturnal hypoglycaemia.
Novo Nordisk faces tough price pressure in its biggest market, the U.S., and slashed its long-term growth guidance in its October earnings, causing shares to plummet.
The company also axed 1,000 jobs and announced the discontinuation of several pipeline projects, including what is commonly referred to as the holy grail among diabetes drugs, insulin in a pill form.
Novo has already applied for a label description update for Tresiba in both the EU and the U.S. after trials earlier this year showed therapy with Tresiba led to fewer episodes of low blood sugar levels (hypoglycaemia) compared to therapy with Lantus.
Novo expects to submit findings from the DEVOTE study for review with regulatory authorities during first half of 2017.
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