The world's largest drug maker, Pfizer has announced that it intends to fast track its inhaled insulin Exubera in India. Exubera received regulatory approvals from the US Food and Drug Administration and the European Commission last week. The drug has been developed in collaboration with Sanofi-Aventis and Nektar Therapeutics.
It is a relatively harmless form of insulin in that no needles or pens or syringes are needed. "Until today, patients with diabetes who need insulin to manage their disease had only one way to treat their condition," said Steven Galson, director of
the FDA's Centre for Drug Evaluation and Research. "It is our hope the availability of inhaled insulin will offer patients more options to better control their blood sugars." In approving Exubera, the FDA stressed that it was not an alternative to injected insulin. "Peak insulin levels were achieved at 49 minutes (range 30 to 90 minutes) with Exubera inhaled insulin, compared to 105 minutes (range 60 to 240 minutes) with regular insulin, respectively," the FDA said in a statement. The drug is to be launched in America in June this year and Pfizer hopes to launch it in India before two years. India already has an estimated 35 million diabetics and a vehicle like Exubera is certain to be welcomed by doctors and patients alike.