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New Analyses Allow Restart Of Ipsen's Palovarotene Clinical Program

FDA's Partial Clinical Hold For Patients Under 14 Remains

 
• By John Davis

Ipsen is to restart a global Phase III study of palovarotene in an ultra-rare bone disorder after additional analyses of interim data, but a partial clinical hold of the compound's use in patients aged under 14 years of age remains in place.    

Restart
• Source: Shutterstock

Ipsen’s aim to develop a pipeline of rare bone disease therapies is partly back on track with the news that it is planning to restart the global Phase III MOVE study of palovarotene in patients aged 14 years or over with fibrodysplasia ossificans progressive (FOP).

However, the US Food and Drug Administration’s partial hold on clinical studies of the drug in patients aged under 14 years with various conditions continues, and the company has decided...

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