7. November 2011 13:08
The EMA is under investigation by the European Anti-Fraud Office (OLAF) over alleged conflicts of interest.
The investigation was raised by Michèle Rivasi, a French Member of the European Parliament, who claims independent oversight by the EMA is impossible due to the majority of its budget coming from pharma.
OLAF told The Independent the investigation opened in July, but “for reasons of judicial secrecy", could not give any further details.
It’s believed the inquiry relates to the Servier’s controversial diabetes drug Mediator. The medication was withdrawn from the European market in 2009, ten years after concerns were first raised the treatment may be responsible for fatal heart problems.
Mediator was on the market for more than three decades and was used as a weight loss drug taken by an estimated 5 million people in France alone, plus countless more in Italy and Spain. It is estimated the drug caused up to 2,000 deaths during its time on the market before it was withdrawn.
The fallout from the scandal saw the French regulator, the Health Products Safety Agency, overhauled and its chief executive resign after an official report found it had “failed in its duties”.
The EMA was formed back in 1995 to provide a collective voice on drug regulation systems in the EU. The Agency has been attempting to its transparency with a series of new working principles and said in October it had “strengthened the rules on how it handles potential conflicts of interest of its staff and experts" after criticism by the Budgetry Control Committee.
A spokesman for the Agency said it was aware of the inquiry but had yet to see any allegations. “We have a robust process for dealing with conflicts of interest. It is transparent and there's no attempt to hide anything,” he said.
18. October 2011 10:59
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The draft guidance recommends the injection as part of a triple and duel therapy regimens for type II diabetics when their control of blood glucose remains or becomes inadequate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.
27. September 2011 16:57
The CHMP has given a positive opinion to Novo Nordisk’s basal insulin analogue Levemir as an add-on treatment in patients with type 2 diabetes.
The opinion is based on a clinical trial where, as an add-on therapy to Victoza, in combination with metformin, reduced glycated haemoglobin (HbA1C) and sustained weight loss were demonstrated.
Alan Moses, Global Chief Medical Officer at Novo Nordisk, says the decision provides an “additional treatment option” for patients who need more options to achieve personalised glucose targets.
Meanwhile, the Committee has also adopted a positive opinion on the extended use of the insulin in children aged between two and five years old with type 1 diabetes.
It reviewed data that showed children treated with Levemir plus a fast-acting insulin analogue experienced a lower rate of all-day and nocturnal hypoglycaemia when compared to those taking human basal insulin and insulin aspart.
Dr Nandu Thalange, Norfolk and Norwich University Hospital, says that when treating children their safety must always come first and welcomed the CHMP’s decision. “Reducing risk of hypoglycaemia – particularly at night – is a vital part of modern management of young children with diabetes,” said Dr Thalange. “Children under six years are at the highest risk of severe hypoglycaemia and other acute diabetes complications, and any treatment which improves safety – not least in this group – is to be welcomed.”
Novo Nordisk now anticipates that the European Commission will shortly approve the usage of Levemir as an add-on therapy to Victoza in patients with type 2 diabetes and extend the marketing authorisation to make the insulin detemir the only basal insulin analogue for the use in this young patient group with type 1 diabetes.
Levemir, Victoza and NovoRapid, another insulin therapy by Novo Nordisk, contributed to a profit increase of 27% for the company in 2010.