Date: 2014-11-25
Type of information: Granting of a Market Authorisation in the EU
Product name: Trulicity™
Compound: dulaglutide
Therapeutic area: Metabolic diseases
Action mechanism: peptide/glucagon-like peptide-1 (GLP-1) receptor agonist. Dulaglutide is a once-weekly, glucagon-like peptide-1 (GLP-1) receptor agonist injectable prescription medicine indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. It has been generated by fusion of a GLP-1 analogue to a modified human immunoglobulin fragment, resulting in a much prolonged half life. Like native GLP-1, dulaglutide leads to an enhancement of glucose-dependent insulin secretion and a reduction of glucagon release.
Company: Eli Lilly (USA - IN)
Disease: type 2 diabetes
Latest news: * On 25 September 2014, the Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Trulicity™, 0.75 mg and 1.5 mg, solution for injection for the treatment of type 2 diabetes mellitus. The benefits with Trulicity are its clinically relevant effect on glycaemic control in patients with type 2 diabetes when used in combination with other glucose-lowering medicinal products including insulin or on its own when metformin cannot be used. Trulicity™ has a beneficial effect on body weight. * On September 18, 2014, Eli Lilly announced that Trulicity™ (dulaglutide) has been approved by the FDA. Trulicity™ is indicated as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes. Lilly plans to make Trulicity 0.75 mg and 1.5 mg single-dose pens available for adults in the United States later this year. This marks the first approval for Trulicity™ anywhere in the world. It has also been submitted to the European Medicines Agency and other regulatory bodies. The biologics license application to the FDA was based on a number of studies of Trulicity™ used alone or in combination with commonly prescribed diabetes medications, including metformin, pioglitazone, glimepiride and insulin lispro. These studies included five large Phase 3 clinical trials from the Assessment of Weekly AdministRation of LY2189265 in Diabetes (AWARD) clinical development program. The efficacy of Trulicity was compared to four commonly used type 2 diabetes medicines: metformin, Januvia®, Byetta® and Lantus®. Trulicity™ comes in a single-dose pen that does not require mixing, measuring or needle attachment. It is administered once a week, any time of day, independent of meals, and should be injected subcutaneously in the abdomen, thigh or upper arm. The recommended starting dose is 0.75 mg, which can be increased to 1.5 mg dose for patients who need additional blood sugar control. Trulicity™ is not recommended as first-line therapy for patients inadequately controlled on diet and exercise. It has not been studied in patients with a history of pancreatitis, and other antidiabetic therapies should be considered for patients with a history of pancreatitis. Trulicity™ is not for the treatment of type 1 diabetes mellitus or diabetic ketoacidosis. Trulicity™ is not a substitute for insulin and has not been studied in combination with basal insulin. Trulicity™ has not been studied in patients with severe gastrointestinal disease, including severe gastroparesis, and is not for patients with pre-existing severe gastrointestinal disease. The labeling for Trulicity™ contains a Boxed Warning regarding increased risk for thyroid C-cell tumors based on studies in rats. In rats, dulaglutide caused a dose-related and treatment-duration-dependent increase in the incidence of thyroid C-cell tumors (adenomas and carcinomas) after lifetime exposure. It is unknown whether Trulicity™ causes thyroid C-cell tumors, including medullary thyroid carcinoma (MTC), in humans as human relevance could not be determined from clinical or nonclinical studies. Trulicity™ is contraindicated in patients with a personal or family history of MTC and in patients with Multiple Endocrine Neoplasia syndrome type 2 (MEN 2). Routine serum calcitonin or thyroid ultrasound monitoring is of uncertain value in patients treated with Trulicity. Patients should be counseled regarding the risk factors and symptoms of thyroid tumors. The FDA is requiring the following post-marketing studies for Trulicity: - a clinical trial to evaluate dosing, efficacy, and safety in pediatric patients; - a study to assess potential effects on sexual maturation, reproduction, and CNS development and function in immature rats; a medullary thyroid carcinoma (MTC) case registry of at least 15 years duration to identify any increase in MTC incidence related to Trulicity; - a clinical trial comparing Trulicity with insulin glargine on glycemic control in patients with type 2 diabetes and moderate or severe renal impairment; and - a cardiovascular outcomes trial to evaluate the cardiovascular risk of Trulicity in patients with high baseline risk of cardiovascular disease. The FDA approved Trulicity with a Risk Evaluation and Mitigation Strategy (REMS), which consists of a communication plan to inform health care professionals about the serious risks associated with Trulicity.
Patents:
Submission of marketing authorization application USA :
Submission of marketing authorization application UE:
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2014-09-18
UE authorization: 2014-11-25
Favourable opinion UE: 2014-09-25
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
