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Third time lucky as MannKind's inhaled insulin is approved

US FDA backs new diabetes treatment Afrezza
MannKind Afrezza insulin diabetes

An inhaled formulation of insulin for diabetes could be back on the market shortly after the US FDA approved MannKind's Affrezza.

The US regulator gave a green light to Afrezza late last week, allowing adults with insulin-dependent diabetes the first alternative to injections since Pfizer's ill-fated Exubera. Pfizer's insulin was taken off the market in 2008 after poor sales.

Afrezza is a short-acting inhaled insulin, a group which represents around 40 per cent of the total prescriptions for insulin. It cost an estimated $1.8bn to bring to market, having been turned down twice before by the FDA in 2010 and 2011.

MannKind's formulation exerts its effects more quickly than injections, so it can be taken at the beginning or even shortly after a meal, while injectable products must be taken beforehand, and clinical trials suggested that the inhaled drug may be less prone to dosing variability than injections.

Estimates of the potential for the drug vary, as much will depend on price and how well MannKind can market the product to healthcare practitioners and patients in light of the demise of Exubera.

Ahead of its backing by an FDA advisory committee earlier this year, several analysts were predicting annual sales $500m a year within five years of launch, although MannKind has always maintained it has $1bn-plus potential.

After the panel endorsed the drug peak sales estimates have rocketed, with some analysts - such as Adnan Butt of RBC Capital Markets - predicting it could reach $5bn-$7bn on the back of the escalating incidence of diabetes around the world.

Others have sounded a note of caution, pointing out that the bulk of the insulin market is accounted for by long-acting, basal insulins such as Sanofi's market-leading Lantus (insulin glargine), which provide a background level of insulin throughout the day.

Short-acting insulins are used to top up insulin levels when most needed, and still represent a multibillion dollar market worldwide, although it is hard to tease out how much of that is accounted for by children or patients who use insulin pumps, neither of which are suitable for Afrezza.

For the time being, it is reserved for use in adults because the insulin cannot cater for the smaller doses required in children with diabetes. The drug should also not be used in patients with asthma or other forms of chronic lung disease, according to the FDA, which notes that administration has led to spasm in the lung of some patients.

Article by
Phil Taylor

30th June 2014

From: Sales



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