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news.Eli Lilly and Company has received marketing authorization from the European Commission for Trulicity (dulaglutide) solution for injection to improve glycaemic control in adults with type 2 diabetes.
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Trulicity, a GLP-1 receptor agonist, is a once-weekly, injectable solution and it comes in a ready-to-use pen with a pre-attached, hidden needle.
In September, Trulicity received a positive recommendation from the Committee for Medicinal Products for Human Use (CHMP).
Lilly Diabetes International vice-president Jeremy Morgan said: "Across the region, diabetes remains a burden on the health system, and we look forward to helping even more patients with type 2 diabetes reach their treatment goals."
The company said that Trulicity 1.5mg once weekly is recommended for those taking Trulicity in combination with other diabetes treatments.
Trulicity 0.75mg once weekly is the recommended dose for patients taking it as monotherapy and can be considered as a starting dose in combination with other diabetes treatments for certain vulnerable populations, including patients aged 75 years and older.
The European marketing authorisation is based, in part, on results from a number of trials, including six large Phase III clinical trials.
In the first five trials, Trulicity 1.5mg was superior to placebo and four commonly used type 2 diabetes medicines in reducing average blood sugar levels (HbA1c).
Trulicity 0.75mg provided similar HbA1c reductions in one of the trials and showed superiority in the other four.
The company said that in the sixth trial, Trulicity 1.5mg showed similar HbA1c reductions to the highest approved dose of a commonly used once-daily GLP-1 receptor agonist.
Trulicity, the once-weekly, GLP-1 receptor agonist injectable prescription medicine, will be available to patients in Europe in 2015.