A new device for injecting tralokinumab is another step closer to approval in European Union Member States.
The European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) has recommended approval of a pre-filled 2 ml pen containing a 300 mg dose of tralokinumab, manufacturer Leo Pharma said in a June 23 announcement. press release.
The interleukin-13 antagonist tralokinumab is now available in 1 ml pre-filled syringes (150 mg).Currently approved for moderate to severe treatment atopic dermatitis Marketed as Adtralza in the European Union, Canada, United Kingdom, United Arab Emirates, Switzerland, Saudi Arabia and Japan. In the US, it is marketed as Adbry and is available in 150 mg dose prefilled syringes.
The new device features a hidden needle and push-down auto-injector. According to the release, the 2ml syringe will allow patients to take one 300mg dose every other week instead of two 150mg doses in a pre-filled syringe. Pending the European Commission’s final decision, the device will be licensed in all her EU member states, Iceland, Norway and Liechtenstein.
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