EU Thumbs Up Signals First-Ever Approval For Leo’s Tralokinumab
UK Regulator Also Expected To Reach Decision On Approval Soon
Leo’s moderate-to-severe atopic dermatitis drug is set to be approved for the first time worldwide.
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Keeping Track: US FDA Says Yes To AZ’s Farxiga In CKD And ADC’s Zynlonta, But No To Leo’s Tralokinumab, Chiesi’s Pegunigalsidase
The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker
A week after getting the thumbs-up from the CHMP for tralokinumab, the Denmark-based dermatology specialist has been hit by a complete response letter from US regulators requesting more data about a device component of the IL-13 inhibitor.
This is an update of recommendations from the European Medicines Agency's Committee for Medicinal Products for Human Use on the authorization of new medicines in the European Union, and updates on EU marketing authorization changes recommended by the CHMP.