Ruxolitinib cream launch date

Ruxolitinib cream, trade nameOpzelura, was approved in the United States in September 2021 for the treatment of mild to moderate atopic dermatitis (AD). It is the first topical Janus kinase inhibitor approved in the United States. In July 2022, ruxolitinib cream was approved for medical use in the United States for the treatment of vitiligo. On February 23, 2023, the European Medicines Agency (EMA) approved the marketing authorization of ruxolitinib cream for the treatment of non-segmental vitiligo, which is also sold under the trade name Opzelura.

The pathophysiology of atopic dermatitis includes skin barrier dysfunction, acute and chronic inflammation, and pruritus. In multiple preclinical models of dermatitis, topical application of ruxolitinib cream significantly improved pathogenic pruritus and skin inflammation. These clinical data strengthen the scientific rationale for topical JAK-STAT pathway inhibition therapy in atopic dermatitis. Ruxolitinib cream has been shown to have beneficial effects on skin pigmentation in patients with non-segmental vitiligo. From a safety perspective, the side effects of ruxolitinib cream are considered acceptable, provided that no more than 10% of the body's total dose is used at one time.

The original drug of ruxolitinib cream has not yet been marketed in China, so it cannot be included in medical insurance. The price of ruxolitinib cream Original drug, specificationsinn 1.5%*60g, which is marketed overseas, is around RMB 20,000 per tube (the price may fluctuate due to the exchange rate), which is relatively expensive. The price of generic ruxolitinib cream marketed overseas is relatively cheap, and its pharmaceutical ingredients are basically the same as those of the original drug. The price of the specificationinn 1.5%*30g produced by a Bangladesh pharmaceutical factory is around 600 yuan per tube (the price may fluctuate due to exchange rate effects).