Bydureon recommended in final NICE guidance

by IainBate 22. February 2012 12:43

Pharma NICE Update Eli Lilly’s Bydureon (exenatide) has been recommended in final guidance in triple or dual therapy regimens as a treatment option for people with type 2 diabetes.

The injection is now available for use on the NHS for patients when their control of blood glucose remains or becomes inadequate in certain circumstances.

Professor Carole Longson, Director, Centre for Health Technology Evaluation at NICE, says that Bydureon has been shown to be a “clinically and cost effective treatment option”.

The convenient prolonged release treatment improves glycaemic control and prevents hyperglycaemia.

In triple therapy regimens in combination with metformin and a sulphonylurea, or metformin and thiazolidinedione, Bydureon is recommended if a person has a certain body mass index (BMI) and has specific psychological or medical problems associated with their weight, or if therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

Bydureon is also recommended in dual therapy regimens in combination with metformin or a sulphonylurea if either of the two together or separately is contraindicated or not tolerated or treatment with thiazolidinediones and DPP-4 inhibitors is contraindicated or not tolerated.

NICE notes that treatment with the medication for both regimens should only be maintained if a beneficial metabolic response has been demonstrated.

Diabetes UK estimates that around 2.25 million people in the UK now suffer from type 2 diabetes.

CHMP recommends Byetta for type 2 diabetes

by IainBate 21. February 2012 12:51

CHMP recommends Byetta for type 2 diabetes - Pharmaceutical Field The CHMP has issued a positive opinion for the use of Byetta (exenatide twice-daily) as an add-on therapy to basal insulin for the treatment of type 2 diabetes in adults who have not achieved adequate glycaemic control.

The treatment, to be used with or without metformin and/or Actos (pioglitazone), demonstrated in clinical trials that it can reduce glycaemic control levels.

Christian Weyer, Senior Vice President, R&D, Amylin Pharmaceuticals, says Byetta “has potential as a complementary treatment approach for several reasons”.

The double-blind, 30-week clinical trial evaluating Byetta as an add-on therapy to insulin glargine showed that patients who may have been at risk of hypoglycaemia reduced their glargine dosage by a fifth.

Then, five weeks after randomisation, all patients had insulin doses titrated to achieve target fasting glucose levels. After the full 30 weeks of treatment, Byetta demonstrated a statistically significant reduction in hypoglycaemia compared to placebo, lowering levels by 1.7% from a baseline of 8.3%.

“Byetta is given in a fixed-dose regimen,” said Christian Weyer. “Its effects contribute to improved glycaemic control after meals, complementing the control of fasting blood sugar achieved with basal insulin. And in a clinical study, patients using Byetta with insulin glargine achieved better glycaemic control, without weight gain or an increased risk of hypoglycaemia, than patients using insulin glargine without Byetta.”

The injection was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA for the treatment of type 2 diabetes.

In November last year, Amylin and Eli Lilly announced they had amicably terminated their decade-long collaboration on the treatment.

NICE confirms Bydureon recommendation

by IainBate 13. January 2012 14:49

Pharma NICE Update NICE has confirmed its recommendation of Eli Lilly’s prolonged release Bydureon (exenatide) for people with type 2 diabetes in final draft guidance.

The guidance recommends the injection as part of triple or dual therapy regimen for patients when their control of blood glucose remains or becomes inadequate in certain circumstances.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE, says that the estimated 2.25 million people in the UK need as many effective treatments as possible to control the condition.

The injection improves glycaemic control by lowering the rise in blood sugar as a result of eating and prevents hyperglycaemia.

In triple therapy regimens in combination with metformin and a sulphonylurea, or metformin and thiazolidinedione, Bydureon is recommended if a person has a certain body mass index (BMI) and has specific psychological or medical problems associated with their weight, or if therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

Bydureon is recommended in dual therapy regimens in combination with metformin or a sulphonylurea if either of the two together or separately is contraindicated or not tolerated or treatment with thiazolidinediones and DPP-4 inhibitors is contraindicated or not tolerated.

NICE says that treatment with the injection for both triple and dual therapy regimens should only be continued if a beneficial metabolic response has been proven.

Metformin, sulphonylureas and thiazolidinediones are other treatments used to lower glucose levels in the blood in the management of type 2 diabetes mellitus.

Lilly and Amylin end diabetes pact

by emma 10. November 2011 12:19

Pharma Industry News

Eli Lilly and Amylin Pharmaceuticals have mutually terminated their decade-long diabetes partnership for exenatide.

As part of the global agreement, Amylin will gain full responsibility for the drug and make an upfront payment of $250 million, plus 15% of future global net sales to Lilly, up to the combined total of $1.2 billion.

Enrique Conterno, President of Lilly Diabetes, said: “This marks an amicable end to a very productive 10-year collaboration that will continue to benefit many people worldwide. Lilly and Amylin are proud of the important accomplishments we achieved together.”

The partnership between Amylin and Lilly provided various innovations to the diabetes market, including Byetta and Bydureon.

Byetta was the first glucagon-like peptide-1 (GLP-1) receptor agonist to be approved by the FDA in April 2005. It is an injectable prescription that improves glucose control in adults with type 2 diabetes mellitus, when used in conjunction with a diet and exercise programme.

Investigational Bydureon received marketing authorisation in the EU in June 2011 for type 2 diabetes, and is currently under review in the US.

Daniel M. Bradbury, President and CEO of Amylin, said: “We anticipate working with one or more partners outside the US in order to maximise the global potential of this innovative molecule and achieve greater operational flexibility and efficiency.”

The mutual agreement confirms that Amylin will resume worldwide drug development and commercialisation, starting in the US and progressing to all markets by the end of 2013.

Diabetes injection preliminarily recommended

by emma 18. October 2011 10:59

Pf NICE update

Eli Lilly’s diabetes injection Bydureon, exenatide prolonged release suspension, has been preliminarily recommended by NICE.

The draft guidance recommends the injection as part of a triple and duel therapy regimens for type II diabetics when their control of blood glucose remains or becomes inadequate in certain circumstances.

Professor Carole Longson, Health Technology Evaluation Centre Director at NICE says the Institute is “pleased” to recommend another treatment option for people with the condition.

The injection improves glycaemic control by lowering the rise in blood sugar from eating and prevents hyperglycaemia.

In triple therapy regimens in combination with metformin and a sulphonylurea, or metformin and thiazolidinedione, Bydureon is recommended if a person has a certain body mass index (BMI) and has specific psychological or medical problems associated with their weight, or if therapy with insulin would have significant occupational implications or weight loss would benefit other significant obesity-related comorbidities.

Bydureon is recommended in dual therapy regimens in combination with metformin or a sulphonylurea if either of the two together or separately is contraindicated or not tolerated or treatment with thiazolidinediones and DPP-4 inhibitors are contraindicated or not tolerated.

NICE says that treatment with the injection for both triple and dual therapy regimen should only be continued if a beneficial metabolic response has been proven.

Final guidance is likely to be published in February 2012.

Eli Lilly expects the drug’s increasing approval to create jobs at its US manufacturing facility in West Chester.

Bydureon was approved by the European Commission to treat type 2 diabetes in June 2011.

Lilly sued over new diabetes alliance

by diana 18. May 2011 16:39

Eli Lilly and Company is being sued by Amylin Pharmaceuticals for engaging in uncompetitive behaviour and violating a strategic alliance between the two companies.

Amylin has accused Lilly of breaching the terms of an agreement regarding the development and commercialisation of exenatide after Lilly partnered with Boehringer Ingelheim (BI) to develop a competing medicine.

In an official statement, Amylin says it selected Lilly as a partner to “promote development and maximise sales” of its exenatide products and is “disappointed” the matter could not be resolved amicably.

Eli Lilly responded by insisting the lawsuit is “without merit” and says it will “vigorously defend” it position.

Exenatide is currently indicated as a first line treatment for type 2 diabetes and is currently under review by the FDA.

The two companies entered into an alliance in 2002 for the worldwide commercialisation and development of exenatide, currently marketed as Byetta (exenatide) injection.

But Amylin claims that Indianapolis-based Lilly engaged in “improper, unlawful and anticompetitive behaviour” by forming a similar alliance with BI to commercialise and develop its linagliptin product – a direct competitor of exenatide-containing medications.

San Diego-based Amylin’s main aim is to prevent Lilly using its sales force from selling both competing products simultaneously, but, despite the litigation, it hopes to continue working with Lilly in the future.

“Amylin is committed to exenatide, a franchise that we believe provides important treatment options for the millions of patients around the world with type 2 diabetes,” a statement said. “Notwithstanding this litigation, we intend to continue to collaborate with Lilly in the development and commercialisation of exenatide products.”

Tags: , , , , ,

News

Trial success for sanofi’s once-daily diabetes treatment

by diana 7. February 2011 17:04

Dr Andrew Hockey Lixisenatide once-daily has been proven to be equally as effective as the current licensed twice-daily therapy in treating type 2 diabetes.

A recent Phase III trial also showed that lixisenatide caused fewer hypoglycaemic events than another GLP-1 receptor agonist, exenatide (Byetta) twice-daily (8 vs. 48 events).

The primary endpoint of the GetGoal-X Phase III study of lixisenatide was non-inferiority in HbA1c reduction from baseline, when used as add-on therapy for people with type 2 diabetes whose condition was inadequately controlled by metformin.

Dr Andrew Hockey (pictured), Director of Medical Operations, sanofi-aventis UK, commented: “The lixisenatide clinical development programme exemplifies our commitment to people with diabetes and our ambition to help them manage their condition more effectively.”

A total of 639 people were involved in the GetGoal-X clinical trial, which had a 24-week main treatment period.

Tags: , , , ,

News

TextBox

Tag cloud

Calendar

<<  May 2016  >>
MoTuWeThFrSaSu
2526272829301
2345678
9101112131415
16171819202122
23242526272829
303112345

View posts in large calendar

Month List