Exubera - Diabetes inhaler insulin drug gets FDA approval

2 February 2006
MUMBAI, INDIA

The Food and Drug Administration has approved an inhaled form of insulin, which is expected to offer alternative to injections for people suffering from diabetes worldwide.

Drugs major Pfizer expects the inhalation therapy for diabetes patients, named Exubera, to rake in sales worth 2 billion dollars globally, as patients embrace the drug which offers less pain. The drug will be available on the stores by May 2006. 

But the regultor, Food and Drug Administration, has put a rider on the approval for the inhalaion drug. It has asked patients to check functioning of their lungs before opting for it as well as every six months. 

This comes in the wake of widespread concerns that Exubera's effects on the lungs have been overlooked.

Reports said that during clinical trials of the much-awaited drug, human volunteers displayed slight disability to breathe.

The inhaler, according to experts, is easier to puff than injecting a syringe. This could be of tremendous impact as the drug becomes available. 

But the cost of the inhalable insulin, which is expected to be on the higher side compared to the injected version, may prove a dampner.

Pfizer, which is the world's largest drug manufacturer, had got the license for the inhalation drug from Nektar, which would be paid fifteen per cent of the royalty from sales of the drug.

Pzifer is expected to announce the price of the diabetes drug soon.

Exhubera is expected to be widely used by Type 1 and Type 2 Diabetes patients.

Experts say inhalers cannot competely turn-down injections. 

In India, which is yet to approve the drug, there are an estimated 35 million diabetes patients. Three per cent of these patients use insulin.