Cosentyx is approved for hidradenitis suppurativa

Company immediately applies to extend its indication to HS in KOR

New option introduced in 10 years after Humira

Confirms efficacy through SUNSHINE·SUNRISE trials

'Cosentyx' has entered the field for hidradenitis suppurativa where no other treatment option than ‘Humira’ had been available until now.

 

Moreover, the company plans to immediately enter the market for the indication in Korea as well.

 

According to industry sources, Novartis Korea recently submitted an application to the Ministry of Food and Drug Safety to extend the indications for its interleukin (IL)-17A inhibitor Cosentyx (secukinumab) to hidradenitis suppurativa (HS).

 

Considering how the indication was approved by the US FDA on the 1st, the company is rapidly preparing to introduce the treatment to Korea.

 

Cosentyx is the first interleukin inhibitor to receive approval for the hidradenitis suppurativa indication and is an achievement made in 10 years after Humira (adalimumab).

 

Hidradenitis suppurativa is characterized by pain and skin lesions such as subcutaneous nodules, abscesses with sinus tract formation, and scars.

 

Repeated inflammation and pus can cause odor, interfering with daily life and adversely affecting the patient’s quality of life.

 

Hot and humid weather makes these symptoms worse, and when the initial inflammation and subcutaneous nodules worsen, sinus tracts can form to the inside of the skin and cause scarring.

 

Its prevalence, which is around 0.00033-4.1% worldwide, has been increasing gradually.

 

According to data from the Health Insurance Review and Assessment Service, about 10,000 patients were reported with hidradenitis suppurativa in Korea as of last year, but the actual number is estimated to be greater.

 

Studies in North America and Europe showed that it occurs more commonly in women, but in Korea, it occurs more commonly in men.

 

Cosentyx's approval was based on the results of the SUNSHINE and SUNRISE trials, which were the largest Phase III clinical trials conducted in the field of hidradenitis suppurativa.

 

Study results showed that the proportion of patients who achieved clinical response (HiSCR50) for hidradenitis suppurativa was higher in the Cosentyx 300mg arm than in the placebo arm when administered every 2 or 4 weeks.

 

Cosentyx for hidradenitis suppurativa is administered at a dose of 300 mg every 4 weeks, and the dose can be increased every 2 weeks if the patient shows inadequate response.

 

In the SUNSHINE study, the percentage of patients achieving HiSCR was 44.5% in the Cosentyx arm, compared to a mere 29.4% in the placebo arm.

 

The HiSCR achievement rates in the SUNRISE study were 38.3% and 26.1%, respectively.

 

In addition, the Cosentyx 300mg 4-week treatment arm also showed a significantly higher HiSCR achievement rate than the placebo arm.

 

In the SUNSHINE study, the HiSCR achievement rate in the Cosentyx 300mg 4-week treatment arm was 41.3%, but 29.4% in the placebo arm.

 

In the SUNRISE study, the rates were 42.5% and 26.1%, respectively.

 

In addition, as a result of exploratory analysis up to 52 weeks of treatment, the HiSCR rate of the Cosentyx arm was sustained through week 52 of the study.