COPENHAGEN, Nov 29 (Reuters) - Novo Nordisk’s long-acting insulin blockbuster Tresiba has a safe cardiovascular profile in patients with type 2 diabetes, results released by the company on Tuesday showed.
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), the Novo statement 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.
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. (Reporting by Nikolaj Skydsgaard, editing by David Evans)