Pfizer's Insulin inhaler gets expert panel recommendation |
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Sat, 10 Sep 2005 06:05
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NEW YORK: Diabetics will soon have an insulin inhaler as Pfizer Inc.'s inhaled insulin powder has been recommended by an experts' panel for U.S. FDA approval. The panel ruled 7-2 that the product could substitute some of the injections diabetics need to control blood sugar.
The product, Exubera, could command an annual sales of $2 billion plus when the 18 million U.S. diabetics would have access to it replacing the insulin shots. Pfizer is developing the drug in collaboration with French pharma major Sanofi-Aventis and Nektar Therapeutics, a small company that invented the insulin formulation and the inhaler.
The advisory panel, in its recommendation, said Exubera can be prescribed for adults with Type 1 diabetes or Type 2 diabetes. It is a short-acting form of insulin taken before meals. Some patients would be required to take long-acting insulin -- by injection.
The panel's acting chairman and endocrinologist Dr Paul Woolf, who voted against the recommendation, warned that the inhaler cannot replace the needle and syringe. He said he is not convinced that patients would get adequate training in how to use the inhaler properly. Another panelist, Dr James Stoller, who also voted against the recommendation, said many diabetics could have undiagnosed lung problems, and the use of Exubera could aggravate these. He called for more data on the effects on lung diseases.
The FDA will now consider the recommendation. While it is not required to accept the recommendation, normally it does not go against it.
There have been doubts among the medical fraternity that inhalation of the drug could affect function of the lungs. While on clinical trials, there were instances of decrease in lung capacity in the initial weeks of treatment in some cases. The changes were found to reverse when the drug was stopped.
Pfizer has said Exubera cannot be used by smokers and the drug was linked in trials to more cases of severe asthma as smoking interfered with the lungs' ability to absorb Exubera.
There are other companies like Eli Lily (with Alkermes), MannKind and Kos Pharmaceuticals working on insulin inhalers. Lilly and Alkermes may not be able to market the product not earlier than 2008, giving Pfizer a clear edge. However, its device is known to be small unlike Exubera, which is larger and has to use compressed air.
Lily and Novo Nordisk make other forms of delivery devices like insulin pens and Pfizer will have clear competition here, feel analysts. Medtronic is another firm, which has a pocket-size device that provides a continuous supply of insulin through an implanted catheter.
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