Three big hopefuls on FDA’s Sept. docket

Share this article:
Three high-profile drugs are expected to come up for votes by FDA advisory committees next month.
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.
Share this article:
You must be a registered member of MMM to post a comment.

Email Newsletters

MM&M Future Leaders

Register now

Early bird $1,950 before 31 October 2014

*Group discounts available on request 


Patient access to pharmaceuticals is a tale of two worlds—affordability has improved for the majority, while the minority is hampered by cost, distribution and red tape. To provide marketers with a well-rounded perspective, MM&M presents this e-book chock full of key insights. Click here to access it.

More in Channel

Five things for pharma marketers to know: Monday, September 15

Five things for pharma marketers to know: ...

Pharma has sought 76 meetings with FDA over biosimilars; Gilead licenses Sovaldi to India generic drugmakers; Pfizer and Ranbaxy Lipitor lawsuit dismissed.

Liraglutide, aiming for new indication, gets new name

Liraglutide, aiming for new indication, gets new name

Why Novo Nordisk is choosing not to leverage Victoza's brand equity as it seeks a weight-loss indication for liraglutide.

Five things for pharma marketers to know: Friday, September 12

Five things for pharma marketers to know: Friday, ...

An FDA panel voted in favor of liraglutide for weight loss; Allergan investors backing an attempted takeover of the firm crossed a critical threshold; and 100 million health wearables are ...