Date: 2013-01-16
Type of information: Granting of a Market Authorisation in the US
Product name: Eperzan™ (EU)/Tanzeum™ (USA)
Compound: albiglutide
Therapeutic area: Metabolic diseases
Action mechanism: Albiglutide is a glucagon-like peptide-1 (GLP-1) receptor agonist. This injectable form of human GLP-1 fuses human GLP-1 to human albumin. It is designed to extend the action of GLP-1 and has potential to allow for weekly injections. GLP-1 is a peptide that acts throughout the body to help maintain normal blood-sugar levels and to control appetite. Normally, GLP-1 levels rise during a meal to help the body use and control the elevation in blood sugar levels. However, GLP-1 is rapidly degraded, resulting in its short duration of action. In people with type 2 diabetes, GLP-1 secretion in response to a meal is reduced.
Company: GSK (UK)
Disease: type 2 diabetes
Latest news: * On April 15, 2014, GSK has announced that the FDA has approved Tanzeum™ (albiglutide) for injection, for subcutaneous use, as a once-weekly treatment for type 2 diabetes. Tanzeum™ has been approved as an adjunct to diet and exercise to improve glycemic control in adults with type 2 diabetes mellitus.The FDA approval of albiglutide is based on the results of GSK’s comprehensive Phase III Harmony programme, consisting of eight trials and involving over 5,000 patients, over 2,000 of whom were treated with Tanzeum. The Harmony studies evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, metformin, glimepiride and pioglitazone, in patients at different stages of the disease, as well as those with renal impairment. Following this approval by the FDA, GSK anticipates the US launch of Tanzeum in the third quarter of 2014. Albiglutide was licensed by the European Medicines Agency in March 2014, under the brand name Eperzan®, for use in adult patients with type 2 diabetes.About diabetesDiabetes is a global epidemic, affecting 382 million individuals globally, over 20 million of whom are in the US. * On March 26, 2014, GSK has announced that the European Commission has granted marketing authorisation for its once-weekly diabetes treatment, Eperzan® (albiglutide). Eperzan® is indicated for the treatment of type 2 diabetes mellitus in adults, to improve glucose control as: -Monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance and -Add-on combination therapy, in combination with other glucose-lowering medicinal products, including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. The EMA authorisation of albiglutide is based on the results of the comprehensive Harmony programme, comprising eight Phase III studies. The Harmony programme involved over 5,000 patients and evaluated albiglutide against commonly-used classes of type 2 diabetes treatment, including insulin, in patients at different stages of the disease, as well as those with renal impairment. Five of the Harmony trials included patient follow-up for up to three years. GSK expects to launch albiglutide in several countries in Europe in Q3-4 2014 with additional launches to follow thereafter. Albiglutide is currently undergoing review by other authorities, including the FDA and the US Prescription Drug User Fee Act (PDUFA) target date is 15 April 2014. * On January 23, 2014, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion recommending marketing authorisation for albiglutide (Eperzan™). The CHMP opinion concerns albiglutide proposed as a once-weekly treatment to improve glycaemic control in adult patients with type 2 diabetes mellitus: - As monotherapy, when diet and exercise alone do not provide adequate glycaemic control in patients for whom the use of metformin is considered inappropriate due to contraindications or intolerance ; - As add-on combination therapy, in combination with other glucose-lowering medicinal products including basal insulin, when these, together with diet and exercise, do not provide adequate glycaemic control. * On August 2, 2013, GSK has announced that the US Prescription Drug User Fee Act (PDUFA) goal date for albiglutide has been extended by three months to 15 April 2014 to provide time for a full review of information submitted by GSK in response to the FDA's requests. * On March 7, 2013, GSK has announced the submission of a Marketing Authorisation Application (MAA) for albiglutide, with the proprietary name Eperzan™, to the European Medicines Agency (EMA). * On January 14, 2013, GSK has announced a regulatory submission to the FDA for albiglutide, an investigational once-weekly treatment for adult patients with type 2 diabetes. Albiglutide is not yet approved as a treatment for type 2 diabetes or any other indication anywhere in the world. GSK intends to submit a regulatory application in the European Union (EU) in early 2013. Last July, the company has completed albiglutide clinical registration package.
Patents:
Submission of marketing authorization application USA : 2013-01-14
Submission of marketing authorization application UE: 2013-03-07
Withdrawal of marketing authorization application USA:
Withdrawal of marketing authorization application UE:
US authorization: 2014-04-15
UE authorization: 2014-03-25
Favourable opinion UE: 2014-01-23
Favourable opinion USA:
Orphan status USA:
Orphan status UE:
Pediatric exclusivit _USA:
Pediatric exclusivity UE: OTC status: Other news:
