European regulators have expanded the license for Pfizer’s Enbrel to include five subtypes of Juvenile Idiopathic Arthritis (JIA), and have also approved a more convenient once-weekly dosing regimen.
The European Commission has now given the all clear for the use of Enbrel (etanercept) in: polyarthritis; extended oligoarthritis (eo-JIA), in children and adolescents from the age of two who haven’t responded or are intolerant to methotrexate; psoriatic arthritis (PsA), in children aged 12 years and above who haven’t responded/are intolerant to methotrexate; and enthesitis-related arthritis (ERA) in those from the age of 12 years who haven’t responded/are intolerant to conventional therapy.
Clearance came on the back of new data from a 12-week open label study which showed that in each of the JIA subtypes studied, the majority of patients met response criteria and demonstrated clinical improvement in secondary endpoints, including the number of tender joints.
The safety profile was also consistent with that observed in other JIA clinical trials, the firm said.
The original paediatric indication for Enbrel was for the treatment of polyarticular JIA, and with its additional approvals the drug has become the only biologic to be cleared for use in more than one subtype of JIA, Pfizer notes.
Commenting on the approval, Bernhard Saller, Medical Lead Inflammation, Europe at Pfizer Specialty Care Business Unit, said it is “an important development for Enbrel as it provides the basis for the use of this therapy by a wider range of patients,” and he noted that the data submitted to support the application includes long-term safety data for up to 10 years in a JIA population.
In addition, the EC has also given the go-ahead for a once-weekly dosing regimen (0.8 mg/kg, up to a maximum of 50mg per dose) as an alternative to the currently-approved twice-weekly dosing regimen (0.4mg/kg, up to a maximum of 25mg per dose), which may offer increased convenience for JIA patients, the company said.
