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Following Positive IIb Study Data, Can 180 Life Sciences Clear The Next Regulatory Hurdle?

MHRA And FDA Need More Information Before Authorization Of Repurposed Adalimumab

 
• By Chloe Kent

180 Life Sciences has found that adalimumab can effectively treat nodule hardness and size in Dupuytren’s disease during a Phase IIb study. But, the company’s CEO Jim Woody tells Generics Bulletin, regulators in the UK and US have requested more information before they will press on with authorization.

Illustration of businessman jumping over hurdle
• Source: Shutterstock

The UK Medicines and Healthcare products Regulatory Agency and the US Food and Drug Administration have both asked California-based biotech 180 Life Sciences for extra information about the use of adalimumab to treat early-stage Dupuytren’s disease following the company’s Phase IIb study results. (Also see "180 Life Sciences Adalimumab Study Publishes Positive IIb Dupuytren’s Disease Data" - Generics Bulletin, 3 June, 2022.)

Both organizations have requested additional information on how the primary and secondary endpoints of the study – nodule hardness and...

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