Janssen Korea said it has launched a follow-up drug of psoriasis treatment Stelara (ingredient: ustekinumab).
The Ministry of Food and Drug Safety on Thursday approved Tremfya Prefilled Syringe Inj. (ingredient: guselkumab).
Tremfya Prefilled Syringe received the indication for the treatment of moderate to severe adult scleroderma requiring phototherapy or systemic therapies.
After the first dose, the drug is administered once after four weeks. Then, the long-acting medication can be administered every eight weeks. The treatment targets Interleukin-23 (IL-23), a type of inflammatory protein.
Tremfya proved effective in VOYAGE1, VOYAGE2 studies on 2,000 patients with moderate to severe plaque psoriasis, Janssen said.
The study results showed that seven out of 10 patients treated with Tremfya achieved PASI (Psoriasis Area and Severity Index) 90.
The PASI score assesses the severity of psoriasis based on the extent of erythema, thickness of scalps and the extent of lesions.
PASI 90 means 90 percent of the symptoms improved and the patient almost recovered to clear skin.
At week 16, patients showed improvements in scalp-related psoriasis, itching, pain, stinging and burning. Nine out of ten Tremfya-treated patients who achieved PASI 90 at week 28 maintained the therapeutic effectiveness at week 48.
Tremfya was potent in patients who did not respond to Stelara treatment.
According to a recent VOYAGE2 follow-up study revealed at the American Academy of Dermatology, 86 percent of 321 patients treated with Tremfya who achieved PASI 90 at week 28 showed PASI 90 at week 72 and demonstrated sustained effectiveness.
Proving its long-lasting efficacy through the several trials, Tremfya won the sales license in the U.S. and Europe last year, and Japan in March.