Pfizer ready to monitor inhaled-insulin patients
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Pfizer Inc is ready to launch a patient-monitoring scheme to assess the safety of its novel inhaled-insulin drug Exubera if the product is approved for use, its worldwide head of development said on Thursday.
Exubera is being developed with Sanofi-Aventis SA and Nektar Therapeutics, and is due to be reviewed by a U.S. Food and Drug Administration (FDA) panel later on Thursday.
Most industry analysts expect a green light for the medicine, which has been touted as a potential $2 billion-a-year seller. But there are concerns about potential adverse effects on the lungs or blood sugar levels.
Pfizer’s development head, Declan Doogan, said the company recognised that using Exubera raised safety issues and the company was therefore prepared for a proper follow-up programme among users.
“This is a new departure and, of course, safety must be a major agenda item,” he told Reuters in a telephone interview during a visit to Britain.
“We have, I believe, a compelling approach to how we are going to evaluate patients in the post-approval world and, of course, we are going to be agreeing that with the regulatory authorities ... I don’t think you will find us resistant.”
Exubera could revolutionise treatment for diabetics by doing away with the need for some, or all, insulin injections.
However, the FDA said in documents released on Wednesday said that the risks involved with using the product needed to be scrutinised closely.
Doogan declined to comment on widespread speculation that Pfizer, the world’s biggest drug maker, was looking to buy its partner Sanofi out of the project, but he confirmed there were talks between the two companies about its future.
“We are in discussions with Sanofi about how the compound will get managed into the future,” he said.
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