Will Rinvoq’s pediatric indication be expanded in KOR?

Company receives approval to start Phase III trial

Will compare the safety and efficacy of RInvoq vs Dupixent in pediatric patients aged 2 to 12 years old

AbbVie Korea will conduct a clinical trial in Korea to expand the indication of its atopic dermatitis drug Rinvoq (upadacitinib) to children aged 2 to 12 years old.

 

On the 24th, the Ministry of Food and Drug Safety (MFDS) approved AbbVie’s application to initiate a Phase III, open-label, blinded trial (START UP) to compare the safety and efficacy of Dupixent (dupilumab) vs RInvoq in children aged 2 to 12 years with moderate-to-severe atopic dermatitis.

 

The trial will be conducted at Gangnam Sacred Heart Hospital, Chung-Ang University Hospital, Konkuk University Medical Center, Korea University Ansan Hospital, Soonchunhyang University Hospital Bucheon, and Seoul National University Hospital.

 

RInvoq can currently be administered once a day to adolescents aged 12 to 17 years weighing 40 kilograms or more.

 

The MFDS-approved label does not recommended for adolescents under 40 kilograms because it has not been studied in the patient population.

 

Other JAK inhibitors used for atopic patients include Eli Lilly’s ‘Olumiant (baricitinib)’ and Pfizer’s ‘Cibinqo (abrocitinib).’ While both are reimbursed for adult patients, only Rinvoq and Cibinqo (for patients 12 years of age and older) and Dupixent (for patients 6 years of age and older) have been available for pediatric and adolescent patients since April of last year.

 

Starting next month, Dupixent will also be reimbursed for infants and children with severe atopic dermatitis aged 6 months and older.

 

In particular, Dupixent is the only pediatric atopic dermatitis treatment that confirmed symptom control and a consistent safety profile in infants, children, and adolescents with moderate-to-severe atopic dermatitis aged 6 months and older through a Phase III clinical study.

 

If the company can generate significant clinical data in children and adolescents aged 2 to 12 years through the new trial, this will allow pediatric atopic dermatitis patients to have broader treatment options.

 

The dosing regimen differs for the two drugs.

 

While Rinvoq is an extended-release tablet that can be taken orally once a day, Dupixent is a subcutaneous injection that is injected into the fatty layer under the skin.

 

Meanwhile, Korean companies are also intent on developing atopic dermatitis drugs in Korea.

 

LG Chem changed the indication o itsf LC510255, a new drug candidate for autoimmune diseases, to atopic dermatitis in the second phase of domestic clinical trials.

 

JW Pharmaceuticals transferred the technology of its atopic drug candidate JW1601 to LEO Pharma in Denmark, but the contract was terminated after the candidate failed to meet the primary endpoint in the initial results of the global Phase IIa/b clinical trial.