First inhaled insulin will be available soon

By Nick Hudson

LONDON (Agence de Presse Medicale for Reuters Health) - The first inhaled insulin (Exubera; Pfizer) has been approved by the U.S. Food and Drug Administration and the European Commission, but is likely to be launched first in the UK, a spokesperson for the company said Monday.

Pfizer announced that the expected blockbuster had been approved by the FDA late Friday, hours after the European Commission also granted marketing authorisation.

A company spokesperson in the UK told APM on Monday that the UK is set to be first in the EU with a launch in May.

However, she indicated that the U.S. would not be far behind because the FDA approval had come earlier than expected. The U.S. launch was originally anticipated to be June or July, she said.

Britain and the United States allow new products to be launched without pricing negotiations. Germany also offers companies the same advantage, so a speedy German launch is also likely, observers noted.

Specialty UK devices maker Bespak, which is gearing up to make the delivery device at its plant in Milton Keynes, Bedfordshire, said the time gap before launch would allow Pfizer to train clinicians and agree upon the product labelling.

Bespak's Chief Executive Mark Thordahl said in a statement on Monday: "We are delighted that both the U.S. and European filings have been approved and we look forward to participating in the commercial success of Exubera by supplying the inhaler device."