A new device for the injection of tralokinumab is one step closer to approval in European Union member states.
The Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency has recommended the approval of a pre-filled 2 ml pen that contains a 300 mg dose of tralokinumab, the manufacturer, Leo Pharma, announced in a June 23 press release.
Tralokinumab, an interleukin-13 antagonist, is currently available in a 1 ml pre-filled syringe (150 mg). It is currently approved for treating moderate to severe atopic dermatitis in the European Union, Canada, Great Britain, the United Arab Emirates, Switzerland, Saudi Arabia, and Japan, where it is marketed as Adtralza. In the United States, it is marketed as Adbry and is available in the 150 mg dose pre-filled syringe.
The new device has a hidden needle and a press-down auto-injection feature. The 2 ml syringe allows patients to take a single 300 mg dose of the drug every other week, instead of two 150 mg doses with the pre-filled syringe, according to the release. Pending the final decision from the European Commission, the device will be authorized in all EU member states, Iceland, Norway, and Liechtenstein.
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