Drug company Pfizer says it is all set to launch a patient-monitoring scheme in order to assess the safety of its novel inhaled-insulin drug Exubera, if the product is approved for use.
Exubera which is being developed with Sanofi-Aventis SA and Nektar Therapeutics, is due to be reviewed by a U.S. Food and Drug Administration panel this week.
It is expected by most industry analysts that the drug will be given the green light, it has been touted as a potential $2 billion-a-year seller.
But some experts are concerned about the drug's potential adverse effects on the lungs or blood sugar levels.
According to Pfizer's development head, Declan Doogan, the company acknowledges that using Exubera might raise some safety issues and the company is therefore prepared for a credited follow-up programme among users.
Doogan says this is a new venture and safety is a major agenda item.
Exubera could revolutionise treatment for diabetics by doing away with the need for some, or all, insulin injections
However, according to documents released on Wednesday, the FDA says that the risks involved with using the product needed to be scrutinised closely.
Doogan has declined to comment on widespread speculation that Pfizer, the world's biggest drug maker, was attempting to buy its partner Sanofi out of the project, but confirms the two companies are in talks about the future and how the product will be managed.
Apparently, following the development of Sutent, an experimental pill against cancers of the kidney and stomach, cancer is also a growing field of focus for Pfizer.