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Associated Press are reporting: FDA Approves Inhalable Version of Insulin
January 27, 2006 06:03:40 PM PST
Quote:
The first inhalable version of insulin won federal approval Friday, giving millions of adult diabetics an alternative to some of the injections they now endure.
The Food and Drug Administration said the Pfizer Inc. insulin, to be marketed as "Exubera," is the first new way of delivering insulin since the discovery of the hormone in the 1920s. Pfizer jointly developed the drug and dispenser with Sanofi-Aventis and Nektar Therapeutics. It should be available to patients by midyear, Pfizer said.
Use of rapid-acting inhaled insulin will not replace the need to inject the hormone occasionally, according to the FDA. And diabetics will have to continue pricking their fingers to test blood sugar levels.
The American Diabetes Association estimated that nearly 21 million people in the United States have diabetes. About 5 million need insulin injections.
Analysts said the inhaled insulin could eventually become a $1 billion-a-year seller for Pfizer, which recently agreed to pay Sanofi-Aventis $1.3 billion to obtain full worldwide rights to the drug for use by both Type 1 and 2 adult diabetics.
"It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars," said Dr. Steven Galson, director of the FDA's Center for Drug Evaluation and Research.
The European Commission approved Exubera for use in adults on Thursday.
In clinical trials, Exubera managed blood sugar levels just as well as injected insulin, but an independent FDA panel in September stressed that use of inhaled insulin will not mean diabetics can toss out the needles, pens or pumps used to inject the hormone.
Inhalable insulin is a welcome advance, said Dr. Nathaniel Clark, the national vice president for clinical affairs for the American Diabetes Association. But he added that needles still will allow a patient to better control dosage.
Dr. Robert Meyer, who oversees the FDA's Division of Metabolic and Endocrine Drugs, said, "We feel like this has been established as a reliable dosage form."
The FDA review panel expressed concern about the bulkiness of the dispenser and about some patients who experienced coughing or a slight decrease in lung capacity when using the drug. Pfizer will study the long-term effects of Exubera on the lungs, as well as its safety and effectiveness in patients with lung disease.
Diabetics with either type of the disease could use the rapid-acting inhaled insulin before or after meals to manage their blood sugar levels. However, the drug would not replace the longer-acting insulin injections that some diabetics, particularly those with Type 1 diabetes, need to take in the morning or before bed.
Elise Rayner, of Colorado Springs, Colo., said she declined to participate in a clinical trial of inhaled insulin.
"My reaction was, I have excellent control of my blood sugars right now and I just don't have any interest in messing with a good thing," said Rayner, 33, who's used both insulin injections and the pump for her Type 1 diabetes.
Most diabetics have Type 2, a condition linked to obesity that occurs when the body cannot effectively use the insulin it makes. In some cases, the disease can be managed with pills when matched with a diet, exercise and weight-management plan.
Pfizer believes Exubera will encourage diabetics who are squeamish about needles to take the insulin. About 15 percent of diagnosed diabetics do not take the insulin or pills they should, the American Diabetes Association estimates.
Better control of blood sugar levels allows diabetics to ward off serious complications, including diseases of the eye, kidneys and nerves. The latter can lead to ulcers and infections in the legs and feet and, in some cases, amputations.
The Exubera device is about the size of an eyeglass case. It delivers insulin, as a dry powder packaged in one- or three-milligram inhalable capsules, to the lungs through the mouth, according to Pfizer.
Diabetics with asthma, poorly controlled or unstable lung disease, or who smoke or recently quit, shouldn't use Exubera, the FDA said. And patients should have their lungs checked before using the drug, as well as at six- to 12-month intervals after that.
"It's not going to be an overnight sensation," said Dr. Robert Goldstein, chief scientific officer for the Juvenile Diabetes Research Foundation International. "My concern is that people will assume they are now free of insulin shots."
Deutsche bank analyst Barbara Ryan said she expects a daily supply of Exubera will cost about $4 to $5. Treatment with injected insulin costs $1 to $1.50, she said.
DaVinci - yes looks like it would have been a good idea last week :( Exubera (inhaled Human Insulin) Approved By European Commission
29 Jan 2006 - 9:00am (UK)
Quote:
Pfizer Inc said today that the European Commission has approved Exubera (inhaled human insulin) for the treatment of adults with type 1 and type 2 diabetes. Exubera is the first non-injectable, inhalable form of insulin to be approved since the discovery of insulin in the 1920s, and represents a major advance in diabetes treatment.
According to the World Health Organization (WHO), diabetes has reached epidemic proportions and affects approximately 48 million people in Europe alone. People with diabetes often suffer from debilitating complications due to uncontrolled blood sugar levels including heart disease, amputation, blindness and kidney failure. The direct healthcare costs associated with diabetes are estimated to be around $286 billion worldwide, with the majority of these costs linked to treating diabetes-related complications.
Since its discovery more than 80 years ago, insulin has been the gold standard treatment for diabetes. In order to achieve tight blood sugar control, insulin is often administered before meals to mimic the body's natural insulin response to food. Healthcare providers and patients have been reluctant to initiate or intensify insulin therapy when it is required due to the need for daily injections.
“Exubera is a major, first-of-its-kind, medical breakthrough that marks another critical step forward in the treatment of diabetes, a disease that has taken an enormous human and economic toll worldwide,” said Hank McKinnell, Pfizer chairman and chief executive officer. “The global incidence of diabetes is currently at epidemic levels. Millions of patients are not achieving or maintaining acceptable blood sugar levels, despite the availability of current therapies. Exubera meets a critical medical need by offering a highly effective and needle-free alternative to diabetes pills and insulin injections to manage this complicated, debilitating disease.”
Exubera is a fast-acting, dry powder formulation of human insulin that is inhaled into the lungs via the mouth before meals using a simple-to-use, hand-held device that does not require batteries or electricity. The device, which weighs four ounces and is about the size of a carrying case for a pair of eye glasses, is designed to deliver an accurate and precise dose of insulin each time it is used.
Exubera is the result of one of the most rigorous and innovative diabetes development programs ever and Pfizer's investment now stands at over $1 billion. Pfizer invested in two state-of-the-art manufacturing facilities -- the world's largest insulin plant in Frankfurt, Germany, and a high-tech facility in Terre Haute, Indiana, U.S. -- well ahead of regulatory actions, so that the product can reach patients as quickly as possible.
The efficacy and safety profile of Exubera was studied in more than 2,500 adults with type 1 and type 2 diabetes for an average duration of 20 months. In studies in adults with type 1 or type 2 diabetes, Exubera was shown to be as effective as injectable insulin in achieving glycemic control. In adults with type 2 diabetes who are not sufficiently controlled with commonly used oral therapies, Exubera has been shown to provide greater improvements in glycemic control. In addition, patients who took Exubera reported greater overall treatment satisfaction and acceptance compared to insulin injections or oral therapies.
"This is really good news for physicians and patients. It is truly a clinical and scientific milestone -- being able to give insulin without needles," said Chantal Mathieu, Professor of Endocrinology, University of Leuven, Belgium. "Physicians face many challenges with insulin therapy due to patients' reluctance to take injections, which up until now, was the only way to take insulin. With Exubera, patients now have another opportunity to take control of their blood sugar and take an active role in managing this complicated disease."
About Exubera
To further support the effective use of Exubera, Pfizer is investing in extensive educational programs to support healthcare professionals and patients.
Exubera is a product of a collaboration between Pfizer Inc and Nektar Therapeutics. Pfizer recently reached an agreement to acquire the sanofi-aventis worldwide rights to Exubera. The two companies were previously in a worldwide alliance to co-develop, co-promote and co-manufacture Exubera.
In the European Union, Exubera has been approved for the treatment of adults with type 2 diabetes (greater than 18 years of age) not adequately controlled with oral antidiabetic agents and requiring insulin therapy. Exubera is also indicated for the treatment of adult patients with type 1 diabetes mellitus, in addition to long or intermediate acting injectable insulin, for whom the potential benefits of adding inhaled insulin outweigh the potential safety concerns.
Exubera is pending approval in the U.S. In September 2005, the U.S. Food and Drug Administration (FDA) Advisory Committee recommended that Exubera should be approved for the treatment of adults with type 1 and type 2 diabetes.
There are two major forms of diabetes -- type 1 and type 2. In type 1, which typically develops in childhood, the insulin-producing cells in the pancreas have been destroyed leading to a complete lack of insulin. In type 2 diabetes, the most common and progressive form of the disease, the body does not effectively use nor produce enough insulin to manage blood sugar levels, and eventually most people with type 2 diabetes will need insulin to achieve blood sugar control.
Important Safety Information about Exubera
The safety profile and tolerability of Exubera have been extensively studied in clinical trials. Adverse events throughout the clinical development program were generally mild to moderate, and discontinuation rates were low.
Patients should not take Exubera if they have poorly controlled or unstable lung disease, or if they smoke or have stopped smoking less than six months prior to starting Exubera treatment. If a patient starts smoking or resumes smoking, he or she must stop using Exubera and see a health care provider about a different treatment.
Before starting treatment with Exubera, a health care provider will carry out a simple test to check lung function. The test involves exhaling into a measuring device. This will help to find out if Exubera is the right treatment for individual patients. Once a patient starts treatment, it is recommended that a health care provider should check lung function again at six months (see full prescribing information).
A small decrease in lung function may occur during Exubera treatment although symptoms might not be noticeable. This change occurs within the first months of treatment and should not worsen as treatment is continued.
Like all medicines, Exubera can cause side effects. As with all forms of insulin, a possible side effect of Exubera is low blood sugar levels.
Some patients have reported a mild cough while taking Exubera, which occurred within seconds to minutes after Exubera inhalation. Coughing occurred less frequently as patients continued to use Exubera.
Consecutive inhalation of three 1mg unit dose blisters causes a significantly higher insulin exposure than inhalation of one 3mg unit dose blister. Therefore, three 1mg unit dose blisters should not be substituted for one 3mg unit dose blister.
The BBC are further reporting: Yeast 'could allow insulin spray'
Diabetes patients could be able to receive insulin via a nasal spray using yeast, scientists believe.
Quote:
Leeds University researchers found the fungus, traditionally used to make beer and bread, opened nasal cells to allow insulin to pass through nose tissue.
They hope it will allow a spray to be developed to replace injections.
A Diabetes UK spokeswoman said it would welcome "any safe, effective advances which make the treatment of diabetes easier and more comfortable".
Getting insulin into the bloodstream through the nose is tricky because the layers of tissue lining the nose, known as the nasal mucosa, can block the molecule.
But in preliminary research, the scientists found that yeast, which is non-toxic, opened up the tight junctions between nasal cells.
Lead researcher Emily Fuller said: "Transport of large molecules, such as insulin, through the nasal mucosa is limited because of the tight structure of the cell layer which forms an impenetrable barrier.
"Our laboratory results show that yeast cells successfully enhanced the penetration of insulin."
The team, which presented its findings at the British Pharmaceutical Conference in Manchester, said more research was needed.
Drug protection
Researchers also said they were looking at yeast's properties as a drug delivery system.
They said it might be possible to encapsulate active drugs inside yeast cells to protect them until they get to the site of action.
Zoe Harrison, care advisor at Diabetes UK, said: "In the UK, there are around 700,000 people with diabetes whose only treatment option is daily insulin injections.
"Although this nasal therapy is in its very early stages, Diabetes UK welcomes any safe, effective advances which make the treatment of diabetes easier and more comfortable.
"We will await the results of the first clinical trials with interest."
The BBC are reporting: Diabetes inhaler rejected for NHS
Quote:
Insulin that can be inhaled rather than injected has been rejected by NHS advisers on grounds of cost.
The drug, Exubera, is designed to offer adults with diabetes an alternative to their daily insulin injections.
Exubera for Type 1 and 2 diabetes costs £1,100 per person per year but patients would still need injections at night.
Campaigners said the draft guidance by the watchdog the National Institute for Health and Clinical Excellence for England and Wales was disappointing.
The inhaled insulin is the first non-injected option for insulin therapy since the discovery of the treatment for diabetes in the 1920s.
About 800,000 people in the UK manage their condition with daily injections.
During clinical trials, researchers found inhaled insulin generally was as effective as injections in controlling blood sugar levels.
The drug has already been given approval by the European licensing body, but the National Institute for Health and Clinical Excellence was testing it on cost-effectiveness grounds for England and Wales.
Charity Diabetes UK said the inhaler was a "medical breakthrough" and access to new developments "should not be restricted on the basis of cost".
A spokesman added: "Many people with diabetes will be deeply disappointed that they are being denied this alternative form of treatment.
"There is an urgent need for more research to support the improvements made by using inhaled insulin on quality of life."
Evidence
Manufacturers Pfizer said: "NICE has dismissed the robust scientific and medical evidence used by international medical experts in the US and Europe to grant widespread approval for this medicine.
"The choice here is quite simple: force patients to keep enduring the burden of multiple daily injections and poor compliance, as they have since the 1920s, or give them an alternative."
NICE said its guidance was not yet final and healthcare professionals and the public could comment before a final statement is published in October.
Andrea Sutcliffe, deputy chief executive at NICE and executive lead for the appraisal, added: "Our review of the evidence indicated that inhaled insulin should not be recommended because it could not be proven to be more clinically or cost effective than existing treatments.
"The clinical experts we asked advised us that using injected insulin is not usually a concern for the majority of people with diabetes."
From Medical News Today: Patient Choice Stops At Inhaled Insulin
01 May 2006
Quote:
An editorial In this week's Issue of THE LANCET calls for physicians and patients to decide on whether It Is appropriate to use Inhaled Insulin for diabetes, even though last week the UK's National Institute for Health and Clinical Excellence (NICE) released its appraisal document on inhaled insulin, open for consultation until May 10, which concluded that the treatment should not be offered to patients. The editorial states: 'NICE supported its conclusion with three main arguments: that the data on quality of life and patient preferences are insufficient and not generalisable; expert views that "using injected insulin is not usually a concern for the majority of people with diabetes"; and, in a rather curious conclusion, NICE claims that the effect that patients might move on to inhaled insulin earlier and therefore avoid or delay long-term diabetic complications, is "insufficient to provide support for a cost-effective use of this technology".
The editorial concludes: 'Inhaled insulin will cost an additional £500 per patient per year. Clearly, it is not suitable for everyone with diabetes. For the group that might arguably benefit most from avoiding or minimising injections--children and adolescents--there is currently insufficient evidence on efficacy and safety. Long-term safety data are still lacking in terms of lung damage and effects on the development of insulin antibodies. With these caveats in mind, however, it should be left to the individual physicians in discussion with their patients to make appropriate use of this new technology.'
Now its the subject of legal action. Medical News Today are reporting: Novo Nordisk Sues Pfizer For Patent Infringement Related To Exubera®
Quote:
Novo Nordisk announced today that the company has filed a lawsuit against Pfizer claiming that Pfizer's product Exubera® infringes patents owned by Novo Nordisk. The patents cover inhaled insulin treatment for diabetes.
The lawsuit, filed in United States Federal Court in the Southern District of New York, alleges that Pfizer willfully infringed the patents and seeks compensatory damages. Novo Nordisk also announced it intends to file a motion for preliminary injunction seeking a court order that would prohibit Pfizer from continuing its unlawful conduct while the lawsuit is in progress.
“Novo Nordisk has been leading the fight against diabetes for more than 80 years,” said Jim Shehan, vice president and general counsel of Novo Nordisk Inc. “We are the only company in the industry with a complete portfolio of insulin analogues to help patients achieve improved control at any stage of their diabetes. We have been able to realize this accomplishment because the patent system enables pioneering companies like ours to continue innovating and pushing for progress in the fight against diseases like diabetes.
“The patents we are asserting are for groundbreaking research on new approaches to treat diabetes,” he added. “As all research-based companies recognize, patent protection is necessary to safeguard the investment that biomedical research requires.”
There is a good summary of the issues just published at Medscape (free login required): Inhaled Insulin: Overcoming Barriers to Insulin Therapy?
From The British Journal of Diabetes and Vascular Disease
Quote:
Abstract
Inhaled insulin is a new route of insulin delivery that can be used in the treatment of type 1 and type 2 diabetes. It offers an alternative and additional means of insulin administration, and has been received with particular satisfaction by patients who dislike injections. Trials indicate that inhaled insulin can be used effectively for pre-meal bolus intensification of treatment. Pre-meal inhaled insulin with Exubera® has shown faster absorption and similar duration of action to regular subcutaneous insulin with an overall similar glucodynamic effect. Although bioavailability is lower, mainly due to losses in the upper airways, this is compensated for by dose. The commonest side effect reported with inhaled insulin, as with subcutaneous insulin, was hypoglycaemia, almost a quarter of patients noted a cough which settled with continued treatment. Increased antibody titres and changes in lung function return to normal on discontinuation of inhaled insulin. Quality of life scores indicate patient preference for inhaled versus injected insulin, thus increased choice may improve adherence to treatment regimens. However, true cost:benefit analyses have to be undertaken as do studies in children, smokers and people with respiratory conditions, e.g. asthma
FDA & EC approve inhaled insulin
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