MedWatch

Leo Pharma expects new FDA ruling for eczema treatment tralokinumab in early 2022

After receiving a complete response letter from the FDA in Spring 2021, Leo Pharma is hoping for a positive result in the first quarter of next year after submitting extra data.

Photo: Leo Pharma / PR

As Leo Pharma rolls out eczema treatment tralokinumab in Europe under the name of Adtralza, it is waiting for a new ruling on the same drug in the US, where it was denied marketing approval last year.

Adtralza made it through the European regulatory process without issue, but hit a stumbling block at the FDA, which wanted additional data on a device component of the treatment. This was later revealed to be the pre-filled syringe used to administer the drug.

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