FDA Approves Bydureon BCise – New Autoinjector to Launch Early 2018

By Jeemin Kwon and Payal Marathe

Easy-to-use Bydureon pen cuts down on the hassle of once-weekly injections by offering convenient mixing, a hidden needle, and more​

Bydureon BCise – an improved pre-filled, single-use pen – has been approved by the FDA for adults with type 2 diabetes taking the once-weekly injectable GLP-1 agonist. The design of the new device incorporates user and healthcare provider feedback on the previous Bydureon dual-chambered pen. The new autoinjector features a simpler mixing process, a hidden needle, and a viewing window for users to confirm that they’ve received the medication. Bydureon BCise is expected to launch in early 2018.

The name “BCise” rhymes with “precise.” Why is the delivery device easier to use?

• Easier mixing: To prep the BCise pen for injection, the user simply has to shake it for 15 seconds. By comparison, the older dual-chambered pen instructed users to tap it “80 times or more.”

• Pre-attached needle: With the dual-chambered pen, users had to screw on the needle cap. Bydureon BCise comes with a hidden needle.

• Easier injection: To administer Bydureon BCise, users are directed to push the pen against the skin and hold for 15 seconds, removing the hassle of needle insertion and holding down the plunger.

To get the new autoinjector, healthcare professionals must write a prescription specifically for Bydureon BCise. As a part of the launch, AstraZeneca will be releasing user-support resources, such as online videos to make learning how to use the device convenient. AstraZeneca has not specified what the price of Bydureon BCise beyond suggesting that it will be comparable to the dual-chambered pen pricing. In the US, GLP-1 agonists tend to cost $20-$25 per day if you are paying entirely out-of-pocket.

Bydureon BCise has also been submitted for European approval; a decision is expected in the second half of 2018. Other injectable GLP-1 agonists available include Victoza (once-daily) and Trulicity (once-weekly). Novo Nordisk’s once-weekly semaglutide is also under FDA review, with a decision expected by the end of 2017.