Korean FDA Approves ‘Atralza’, a Competitor to ‘Dupixent’, for Atopic Dermatitis Treatment

‘Atralza’ Enters the Korean Market as a Promising Treatment for Atopic Dermatitis

The Korean Food and Drug Administration has recently approved ‘Atralza’, a potential rival to ‘Dupixent’, for the treatment of atopic dermatitis. This breakthrough offers new hope to patients suffering from the condition.

Newly Approved Drug for Atopic Dermatitis

The Ministry of Food and Drug Safety, led by Minister Oh Yoo-kyung, has granted approval for the use of ‘Atralza Free Filled Systrell 150mg’, which contains the key ingredient traloquinunap. This medication is specifically designed to address moderate to severe cases of atopic dermatitis.

Intended for adults and adolescents aged 12 and above, ‘Atralza’ is recommended when topical treatments fail to adequately control symptoms or are not suitable. By targeting this specific patient group, the drug aims to provide effective relief for those who require systemic therapy.

A New Approach to Atopic Dermatitis Treatment

The remarkable feature of ‘Atralza’ lies in its mechanism of action. This groundbreaking treatment is a humanized monoclonal antibody that specifically targets the interleukin-13 (IL-13) pathway. By inhibiting the signal transduction of interleukin receptors, ‘Atralza’ holds the potential to alleviate the discomfort and irritation caused by atopic dermatitis.

As a responsible regulatory body, the Ministry of Food and Drug Safety hopes to expand treatment options for domestic patients. By prioritizing safety and efficacy, along with their expertise in regulatory science, they aim to promptly deliver reliable treatments to those in need.

‘Atralza’, a treatment for atopic dermatitis, which is considered a rival to ‘Dupixent’ in the foreign market, has opened the door to the Korean Food and Drug Administration.

The Ministry of Food and Drug Safety (Minister Oh Yoo-kyung) announced on the 31st that it has approved the new drug ‘Atraloza Free Filled Systrell 150mg’ (ingredient traloquinunap) used for the treatment of atopic dermatitis.

According to the Food and Drug Safety Administration, this drug is used for adults and adolescents over 12 years of age as a treatment for moderate to severe atopic dermatitis that is not controlled by topical treatment or where topical treatment is not recommended.

The indication for Atralza is the treatment of moderate to severe atopic dermatitis in adults (18 years of age or older) and adolescents (12 to 17 years of age) who are not adequately controlled by topical treatments or who are not receiving these treatments recommend them for them. adults (18 years or older) and adolescents (12 to 17 years) are the targets of systemic therapy.

The Food and Drug Safety Administration explained that Atralza is a humanized monoclonal antibody that binds to interleukin-13 (IL-13) and may provide a new treatment opportunity for patients with atopic dermatitis by inhibiting interleukin receptor sub-signal transduction that n cause irritation. respond.

An official from the Ministry of Food and Drug Safety said, “We will continue to do our best to expand treatment opportunities for domestic patients by promptly supplying treatments whose safety and efficacy have been sufficiently confirmed based on our expertise in regulatory science.”

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