1. Generics Bulletin
  2. >>Policy & Regulation
  3. >>Regulation

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

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Generics Bulletin for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

More from Policy & Regulation

Trump Order On Domestic Manufacturing Wins Plaudits From Industry

 
• By Dave Wallace

An executive order from US president Donald Trump aimed at incentivizing domestic manufacturing of critical medicines has been welcomed by the US Association for Accessible Medicines.

Teva And Alvotech Celebrate Interchangeability For US Ustekinumab

 
• By Dave Wallace

The market for biosimilar rivals to Stelara continues to be hotly contested in the US, with partners Teva and Alvotech claiming a boost from an interchangeability designation at the same time as Biocon Biologics highlighted fresh market access agreements.

Medicines UK Welcomes NHS England’s Best-Value Biologics Biosimilar Adoption Framework

 
• By Adam Zamecnik

Reflecting on recent initiatives by NHS England and the MHRA, the newly renamed trade body Medicines UK has welcomed efforts in promoting the use of biosimilars in Britain.