Final NICE guidance on the use of Daxas (roflumilast), Merck Sharp and Dohme’s drug for maintenance treatment of severe chronic obstructive pulmonary disorder (COPD), recommends setting up a clinical trial to test its clinical and cost-effectiveness.

The Appraisal Committee confirmed draft guidance, which was not challenged, on the potential use of Daxas as an add-on to double or triple bronchodilator drug therapy for adults with severe COPD and a history of frequent exacerbations.

It is estimated that 88,000 people with COPD would be eligible for long-term treatment with Daxas in the suggested indication by 2015; however, the lack of relevant direct clinical trial evidence for the drug’s value in this context led the NICE Appraisal Committee to demand more robust data.

Daxas, an oral medication, is a long-acting enzyme inhibitor that targets cells and mediators important whose inflammation is believed to cause COPD.

NICE recommends use of the drug on an ‘only in research’ basis to generate relevant data about its benefits as an add-on to triple therapy (long-acting muscarinic antagonists plus long-acting beta2 agonists plus inhaled corticosteroids) or dual therapy (the first two of these).

Professor Carole Longson, NICE Health Technology Evaluation Centre Director, said: “There are a lot of people with COPD, and those likely to be treated with roflumilast could receive treatment for a long time. This meant that a high degree of uncertainty about the clinical and cost-effectiveness was not acceptable to the Committee.

“For this reason, the Committee has recommended a clinical trial of roflumilast in the same combination in which it would be used in clinical practice.”

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The draft guidance recommends the injection as part of a triple and duel therapy regimens for type II diabetics when their control of blood glucose remains or becomes inadequate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

Boehringer Ingelheim and Eli Lilly have launched Trajenta (linagliptin), a single dose, once-daily tablet for adults with type II diabetes mellitus (T2DM) in the UK.

Trajenta has been shown to deliver significant HbA1c reductions compared to placebo and was generally well tolerated in clinical trials involving more than 4,000 patients.

Professor Anthony Barnett, Consultant Physician and Emeritus Professor of Medicine, Heart of England NHS Foundation Trust and University of Birmingham, says its release is “an important advance in the management” of diabetes.

The drug is licensed for adults with T2MD as a monotherapy in patients inadequately controlled by diet and exercise alone, and for whom metformin is inappropriate due to intolerance, or contraindicated due to renal impairment.

It is also licensed in combination with metformin when diet and exercise plus metformin alone do not provide adequate glycaemic control; and in combination with a sulphonylurea and metformin when diet and exercise plus dual therapy with these medicinal products do not provide adequate glycaemic control.

In clinical trials, a mean HbA1c reduction from baseline of 0.7% was sustained over 102 weeks as add on to metformin and a sulphonylurea in patients using Trajenta.

Around a third of people with diabetes are affected by chronic kidney disease. The convenient tablet is the only dipeptidyl peptidase-4 (DDP-4) inhibitor which is primarily excreted via the bile, and the first in this class licensed for use in T2DM, irrespective of degree of renal impairment.

“Linagliptin offers the benefits of the DPP-4 inhibitor class with good tolerability, weight neutrality and low risk of hypoglycaemia and the additional advantage of health professionals being able to prescribe without dose adjustment irrespective of the patient's renal function,” added Professor Anthony Barnett. “Renal impairment is common in people with type 2 diabetes so this latter point is extremely important.”