Three big hopefuls on FDA’s Sept. docket
The drugs -- Pfizer's inhaled insulin Exubera for diabetes and Bristol-Myers Squibbs' Pargluva for adult-onset diabetes and Orencia for rheumatoid arthritis -- each could have $1 billion in sales, The Wall Street Journal notes. Exubera will be the subject of a Sept. 8 meeting, while Orencia and Pargluva are scheduled to face scrutiny Sept. 6 and 9, respectively.
Exubera would be the first inhalable form of insulin, providing a long-awaited alternative to injections. According to Pfizer, the FDA, as well as Europe's regulatory agency EMEA, are reviewing applications to market the drug for adults with type 1 and type 2 diabetes.
The drug is being jointly developed by the Sanofi-Aventis Group and Pfizer. Another partner, Nektar Therapeutics developed the inhalation device and the technique for spray-drying insulin into powdered form.
Bristol-Myers' Pargluva would be marketed with Merck and aimed at patients with type 2 diabetes. In addition to helping control patients' blood sugar, the drug has been shown to bring down triglycerides in the blood, as well as to lower LDLs, or "bad" cholesterol, while raising HDLs, or "good" cholesterol.
Pargluva and Exubera have been linked to side effects, something the advisory committees will consider closely. And Orencia is slated to come before the same committee that handled COX-2s, which are currently at the center of a debate over the risks of medicines.