Our First Peek at Bydureon: “Connect, Shake, Inject”

During our recent trip to Portugal for the 47th Annual Meeting of EASD, we had the chance to see the once-weekly GLP-1 drug Bydureon for the first time since its European approval in June as a treatment for type 2 diabetes (for readers in the EU, please click here to see a picture of Bydureon; the product is not yet approved in the US). As we’ve written previously, unlike the other currently available GLP-1’s Byetta and Victoza, Bydureon requires reconstitution (mixing the drug with a liquid) before its use. Even so, demonstrators at the conference made the process of giving yourself a Bydureon shot look fairly simple. Stressing the cool, memorable phrase “Connect, Shake, Inject,” administering Bydureon includes the following steps:

• Step 1:Connect a vial that contains the drug powder to a syringe that contains the diluent (the liquid that dissolves the drug powder) using a special connector piece.

• Step 2: Inject the diluent in the syringe into the vial with drug powder.

• Step 3: Shake the mixture.

• Step 4: Draw up the mixture into the syringe.

• Step 5: Place the needle onto the syringe.

• Step 6: Inject the drug.

For those that have used an emergency glucagon kit, it’s basically the same idea. Because the components that make up the Bydureon drug are quite large, a larger needle (23 gauge, 7.8 mm long) is used with Bydureon than for glucagon. Victoza, Byetta, and insulin needles can be as small as 32 gauge and 4 mm long. We have heard from Amylin, Eli Lilly, and Alkermes (the companies that are partnering on Bydureon) that a pen for Bydureon is currently under development and that it may be available by late 2012. While we believe that the pen will greatly simplify the process, the needle size used with the pen will likely remain the same. As indicated above, Bydureon is not yet available in the US, but it has been recently resubmitted to the Food and Drug Agency (FDA), placing the drug’s next possible approval date on January 28, 2012. We would be very surprised if the FDA doesn’t grant its approval in early 2012. --BK