Ipsen is set to restart palovarotene dosing in participants aged 14 and above in its clinical programme of fibrodysplasia ossificans progressiva (FOP).
The company noted that the US Food and Drug Administration (FDA) did not find any safety concerns with reinitiating dosing in this patient population.
In addition, the company received clearance from regulatory agencies in the UK, France, Sweden, Italy, Argentina, Canada, and Spain.
In January this year, Ipsen decided to temporarily halt dosing in the Phase III MOVE trial and the ongoing Phase II extension studies in FOP based on data from a futility analysis.
According to the company, preliminary post-hoc analyses of interim results showed encouraging therapeutic activity with palovarotene.
The company revised the protocol for the Phase III MOVE trial and included statistical analysis updates recommended by the Independent Data Monitoring Committee (IDMC).
These updates enable more analyses in addition to the primary pre-specified analysis.
IDMC noted that the pre-specified statistical model may have negatively impacted the efficacy analysis.
Ipsen Research and Development head Dr Howard Mayer said: “We are pleased that Ipsen has received the approval to reinitiate dosing in patients 14 years of age and older in the Phase III MOVE trial from several regulatory agencies to date following review of the additional data.
“After consultation with patient groups and investigators, we have been working diligently with all relevant stakeholders to restart the trial as quickly as possible.”
The company is currently seeking approvals from the ethics committee (EC) of each clinical site.
The partial clinical hold issued by the FDA in December last year for the paediatric population aged below 14 years with FOP and multiple osteochondroma (MO) is still in effect.
Meanwhile, Ipsen has decided to terminate its MO-Ped trial (PVO-2A-201).
