Monday, January 30, 2006

Inhaled Insulin Approved by FDA (from Medscape)

Inhaled Insulin Approved by FDA

Daniel J. DeNoon

Jan. 27, 2006 — The first inhaled insulin (Exubera) was approved today by the US Food and Drug Administration (FDA) for the treatment of adult patients with type 1 and type 2 diabetes. An inhaled powder form of recombinant human insulin (rDNA), the drug and delivery system is the first new insulin formulation introduced since the discovery of insulin in the 1920s, according to the FDA.

The FDA approval requires the manufacturer to distribute medication guides along with Exubera. The guide contains FDA-approved information written especially for patients.

Exubera is not to be used by smokers or people who have quit smoking within the previous 6 months, according to the FDA. It is also not recommended for people with asthma, bronchitis, or emphysema. However, people with colds or or other upper respiratory infection should still be able to take the drug, although it may cause coughing.

The FDA recommends pulmonary function testing prior to starting inhaled insulin and then every 6 to 12 months thereafter.

The treatment has been in development for 10 years in a joint effort by Pfizer, Sanofi-Aventis, and Nektar Therapeutics. Earlier this month Pfizer bought Sanofi-Aventis' rights to Exubera.

"Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition," Steven Galson, MD, director of the FDA's Center for Drug Evaluation and Research, says in a news release. "It is our hope that the availability of inhaled insulin will offer patients more options to better control their blood sugars."

The device that administers the insulin is not as small as an asthma inhaler. Folded up, it is the size of a standard flashlight. A retractable inhaler tube comes out from the body of the device; when extended it reaches from the chest to the mouth. A blister pack of insulin then must be inserted before the device is triggered. Patients and doctors will get extensive training on how to use Exubera.

Inhaled insulin is not the only alternative form in development. Others include insulin mouth sprays, insulin patches, and even oral forms of insulin. And other companies — notably a collaboration between Eli Lilly & Co. and Alkermes Inc. — are racing to develop their own versions of insulin inhalers.

Concern Over Lung Safety

The FDA approval of Exubera follows a 7-2 vote recommending approval by a panel of expert advisors. The advisory panel — in a 5-4 vote — also called for new studies of Exubera's long-term safety in people with underlying lung disease.

The FDA's approval requires the manufacturer to perform long-term studies to confirm Exubera's safety.

The drug is approved for treatment of both type 1 and type 2 diabetes. However, clinical trials found that fewer than 30% of people with type 1 diabetes were able to reduce their blood sugar to recommended levels after 6 months of treatment with the inhaled insulin.

Pfizer and Sanofi-Aventis did not seek FDA approval for Exubera in children and teenagers. Early trials in children were stopped due to concerns about Exubera's effects on children's breathing. The companies plan to restart pediatric studies after consultation with the FDA.

The European Union yesterday approved Exubera for treatment of type 1 and type 2 diabetes in adults.

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