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Exubera inches closer

Inhaled insulin drug recommended for approval, as manufacturers commit to continuing research about its safety

Pfizer and sanofi-aventis' novel inhaled-insulin drug Exubera is one step closer to reaching the market, after a US Food and Drug Administration (FDA) advisory committee recommended the drug's approval despite safety concerns.

The panel voted 7-2 in favour of Exubera being used for both Type I and Type II diabetes despite the drug being linked to a small reduction in lung function.

Exubera is now widely expected to gain full FDA approval later this week and is touted as a potential $2bn-a-year blockbuster. If approved, it could be made available as early as mid-2006.

Pfizer has confirmed that it has already drawn up a patient support programme for Exubera, which would help to monitor the safety of the drug.

Speaking to Reuters, Pfizer's head of global R&D, Declan Doogan said the company recognised that using Exubera raised safety issues and that it was committed to continuing research about the drug's safety if it wins approval.

ìWe have, I believe, a compelling approach to how we are going to evaluate patients in the post-approval world,î he said.

Pfizer spokeswoman Vanessa Aristide said Exubera would be fulfilling an unmet need.

ìThere are about 18 million diabetes patients in the US alone and many of those with Type 2 diabetes may not be sufficiently controlling their blood sugar levels,î she said. ìExubera would provide a new option that cuts down the need for insulin injections and might convince those individuals who may have delayed insulin use to seek help.î

Tim Anderson, pharmaceutical analyst at Prudential Equity Group, said he thought the FDA would follow up with full approval. ìThere are still some major issues that are going to be worked out with the FDA, but some major hurdles have been crossed,î he commented.

Exubera's path to market has been fraught with delays: doubts about the drug arose when one diabetic patient who received the experimental therapy was diagnosed with pulmonary fibrosis, a condition that scars the lungs and eventually leads to death.

Aristide said it was ìimpossible to speculateî on what the labelling for Exubera would be likely to include.

Exubera was developed out of a venture between Pfizer, sanofi-aventis and Nektar Therapeutics and would be the world's first inhaled insulin drug on the market. A similar treatment, being developed by Eli Lilly and Alkermes, is currently in phase III clinical trials.

30th September 2008

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