Lillygains Registration Approval in the UAE for Trulicity® (dulaglutide), its Weekly Non Insulin Injection for Type 2 Diabetes
Last Update: Wednesday, December 17, 2014 : 12:07 (+4GMT)
Approval marks first registration in the region and in the world, just after the FDA and Europe
Dubai, 17 December 2014– Today, the UAE ministry of healthannounced granting the marketing authorisation for Lilly’s Trulicity® (dulaglutide) solution for injection, a once-weekly, injectable solution designed to improve glycaemic control in adults with type 2 diabetes.
The UAE marketing authorization announcement of Lilly’s new diabetes treatment is the first in the region and in the world , after the FDA and the marketing authorization granted by the European Medicines Agency.
It belongs to a category of drugs called glucagon-like peptide-1 (GLP-1) receptor agonists. It acts like GLP-1, a natural hormone, helping the body release its own insulin when patients eat. It comes in a ready-to-use penwith a pre-attached, hidden needle.
It is indicated to improve glycaemic control in adults with type 2 diabetes in combination with other glucose-lowering medicines, or as monotherapy and can be taken any time of day, with or without meals.
The most common side effects reported include mild to moderate nausea and, when used in combination with insulin, low blood sugar. These adverse events are consistent with those seen with other GLP-1 receptor agonists.
“Trulicity’s approval in the UAE, just after the FDA and EU approvals represents UAE ‘s commitment to support an innovative driven healthcare environment and Lilly’s commitment to provide solutions for people living with diabetes through innovative treatments ” said Huzur Devletsah, Managing Director of the Middle East Region for Lilly , the US based pharmaceutical company.
It has received approval from the U.S. Food and Drug Administration on 18 September 2014, and EU approval on 21 November 2014, the same week of receiving the UAE approval. It will be available for patients in the UAE by the first quarter of 2015.
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