|From the Forbes article...a while back|
My view is that the FDA is going to set a very high bar for approving inhaled insulin. The FDA sees delivering drugs through the pulmonary route as a different dosing form. In the FDA's view, the benefit is primarily convenience. In other words, the regulators seem to discount the fact that convenience promotes compliance, which leads to better health outcomes. Therefore, the agency will be extra-cautious in making sure inhaled insulin is safe. For example, the FDA requires two years of safety data, while other forms of injected insulin have been approved on one-year or even six-month data.
Exubera, a dry powder, is inhaled into the lungs before meals. Needles aren't used, and the drug is quickly absorbed into the bloodstream. Nektar scientists took the product through phase I clinical trials and then licensed the technology for further development and commercialization to Pfizer and Aventis. Pfizer and Aventis have a global agreement to co-develop, co-promote and co-manufacture inhaled insulin. Nektar is responsible for manufacturing the fine-insulin powders and supplying the inhalers.
Exubera is awaiting European approval. The companies are planning to file with the FDA for U.S. approval of Exubera by mid-2005. In its deal with Pfizer, Nektar will get 15 percent of all revenue from the product.