Olumiant set the first milestone for circular hair loss

Waiting for demand for the first treatment

7.4 million won a year cost stumbling block.

As Olumiant is listed as a treatment for severe alopecia areata in adults for the first time in Korea, expectations are growing as to how much impact it will have.

 

Experts say that there are many positive factors, such as increased interest in hair loss disease, as it is a treatment that has already been in high demand.

 

However, some point out that future tasks such as a clear distinction between mild and severe in alopecia areata and the establishment of guidelines must be preempted in order for new indications to quickly take root.

 

According to the pharmaceutical industry on the 4th, the Ministry of Food and Drug Safety approved Lilly's oral JAK inhibitor Olumiant as the first treatment for severe alopecia areata in adults in Korea.

 

A specific target is severe alopecia areata in adult patients aged 18 years or older.

 

It is true that there was no approved treatment for alopecia areata before the approval of Olumiant.

 

Previously recommended treatments had limited evidence to support their effectiveness.

 

Professor Kim Moon-beom (Pusan National University Hospital, Dermatology), president of the Korean Hair Society, said, "Severe alopecia areata has suffered from treatment limitations due to the low public awareness of alopecia areata and the absence of approved drugs for patients with alopecia areata." The society has already started efforts to improve the treatment environment for patients with severe alopecia areata through the revision of the treatment guidelines since last year.” Won Jong-hyeon, public relations director of the Hair Society (Seoul Asan Medical Center, Dermatology Department) said, "It is a drug that has been in standby demand for patients with severe hair loss, so it is expected that prescriptions and intake will become active with approval." It is positive that it has become a new hope for hair loss patients or patients who have experienced side effects for which the existing immunosuppressive treatment was not easy.” Olumiant's approval for severe alopecia areata in adults was based on the randomized, double-blind, placebo-controlled Phase 3 clinical trials BRAVE-AA1 and BRAVE-AA2.

 

Both studies included Korea.

 

The primary endpoint of the BRAVE-AA1 and BRAVE-AA2 studies was the proportion of patients achieving a SALT score of 20 or less (more than 80% hair-covered scalp) at week 36.

 

Olumiant 2mg and 4mg showed superiority to placebo in terms of hair regrowth effect at 36 weeks.

 

In BRAVE-AA1, the rates of achieving a SALT score of 20 points or less at week 36 of the Olumiant-administered group were 38.8% (4mg) and 22.8% (2mg), which were statistically significantly higher than 6.2% of the control group (placebo).

 

If so, can Olumiant's indication for severe alopecia areata in adults leads to immediate prescription as long as there was a waiting demand?

 

In the clinical field, in order for new drugs to take root more quickly, it is the view that a clear distinction between severe and mild conditions in alopecia areata and the establishment of a treatment guide should be given priority.

 

According to the guideline for the treatment of alopecia areata published last year by the Hair Society, oral JAK inhibitors are systemic immunosuppressive agents (systemic steroid ± oral cyclosporine therapy) or diphenylcyclopropenone, DPCP and It is recommended as a first-line treatment agent.

 

Regarding this, PR director Won said, "For future prescriptions, it is expected that the risk of side effects, including age, tumor occurrence, and presence of comorbidities, will be considered." The aspect of being able to do so will also be a consideration in the prescription,” he explained.