An FDA review panel gave the go ahead for Exubera to go on the US market. The Endocrinologic and Metabolic Drugs Advisory Committee approved a new inhaled version of insulin by a vote of 7-2. Supporters say Exubera, which was developed in a three-way partnership by Pfizer, Sanofi-Aventis and Nektar Therapeutics, represents a major advance for diabetics, who until now had no choice but to endure often painful daily injections.
The approval came despite concern on the part of some specialists about the drug's long-term impact on the lungs of users, particularly those with pre-existing breathing problems or a history of smoking. Citing those concerns, the three companies offered to do a series of long-term studies on the pulmonary impact of the drug on users which would run through 2019.
- see this story from The Washington Post