FDA ADVISERS SAY EXUBERA'S BENEFITS OUTWEIGH ITS RISKS
Pfizer and sanofi-aventis' potential breakthrough diabetes drug Exubera has received the green light from an FDA advisory panel, which recently voted 7-2 to recommend approval for the inhaled insulin powder.
Members of the agency's Endocrinologic and Metabolic Drugs Advisory Committee expressed a variety of concerns about Exubera (inhaled powder insulin), but ultimately concluded that the drug's benefits outweigh its risks. Developed jointly by Pfizer and sanofi-aventis, Exubera is a potential blockbuster drug that, if approved, would be the first inhaled insulin powder available on the U.S. market. The product, which is self-administered using an inhaler, is highly anticipated by diabetics, many of whom want an alternative to insulin injections, the current standard of treatment.
FDA scientists who reviewed Exubera's new drug application identified a number of potential safety risks with the drug, including respiratory problems and hypoglycemia, but the advisory panel determined the health risks shouldn't prevent the product from being approved. For example, a large number of clinical trial participants reported experiencing cough when taking Exubera, but the panel found the severity of the coughing problems were generally mild. Pfizer's representative offered a similar conclusion, saying that a close review of adverse-event reports revealed that most coughing problems amounted to patients having to clear their throat after using the Exubera inhaler.
The FDA advisers also expressed concerns that there appears to be a large learning curve when it comes to using Exubera. Clinical studies showed a wide variation of dosing among new users of Exubera, a problem that was largely attributed to patients' unfamiliarity with the inhaler. In light of the potential dosing problems, the panel said comprehensive training would be necessary for the product, but the committee stopped short of making specific recommendations. Several advisers noted, however, that Pfizer has yet to explain how it intends to provide training to patients and doctors.
In the end, the advisers seemed to focus on the overwhelming convenience Exubera would bring to diabetics. The advisory committee's patient advocate, a diabetic herself, called the possibility of not having to use a needle to administer insulin "irresistible."