Exubera receives FDA vote of confidence
pharmafile | September 9, 2005 | News story | Research and Development, Sales and Marketing |Â Â Â
Exubera, the first inhaled insulin treatment for diabetes, has moved a step closer to US approval following recommendation approval from an FDA advisory committee.
Co-developed by Pfizer and Sanofi-Aventis, Exubera has endured a three-year delay in its journey to market but could now revolutionise the lives of millions of diabetes sufferers in the US.
Exubera's approval has been delayed over concerns it might hamper lung function and questions over its efficacy in multiple types of diabetes.
In response to these concerns, Pfizer has offered to run a risk-monitoring system to monitor the drug's affects on large patient populations.
The advisory panel voted 7-2 in favour of Exubera's approval for the treatment of type I and type II diabetes for adults without lung problems and who do not smoke.
The FDA, while not required to follow its committee's recommendation, usually does and a formal decision could come by October this year.
Exubera's revolutionary status rests on its ability to offer diabetes sufferers a needle-free way to treat their disease and analysts have estimated that Exubera's earnings could top $2 billion.
There are up to 18 million diabetics in the US but compliance issues due to patients aversion to syringes have always compromised injected insulin therapy.
Exubera closely mimics the normal physiological insulin response to meals by quickly being absorbed into the bloodstream to reduce meal-related spikes in glucose levels in people with diabetes.
Pfizer has earmarked Exubera as part of its plans to offset about $14 billion in lost sales owing to a number of patent expiries over the next several years.
New diabetes drugs have, however, proven to be one of the most hazardous drug development areas, with a number of high-profile industry failures.
But several companies are working on inhaled insulin devices, including Kos Pharmaceuticals and Novo Nordisk while Lilly and Alkermes are co-developing a treatment currently undergoing phase III trials.
Exubera, developed by Nektar Therapeutics, but licensed to Pfizer and Sanofi-Aventis has also been submitted for approval to the EMEA with a decision expected shortly.
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