FDA approves the first topical JAK inhibitor to treat atopic dermatitis

On September 21, Incyte announced that the FDA approved Opzelura (ruxolitinib) cream for short-term and non-continuous long-term treatment of non-immune-compromised patients with mild to moderate atopic dermatitis (AD). The condition of these patients cannot be adequately controlled by the existing local prescription therapies, or the existing therapies are not applicable. Opzelura is the first and only topical JAK inhibitor approved by the FDA.

Atopic dermatitis (AD) is a special type of eczema, characterized by inflammation and intense itching. It is a chronic skin disease that affects more than 21 million people in the United States. Symptoms and signs of AD include skin inflammation and itching, which may cause red lesions, oozing, and crusting. AD patients are also more susceptible to bacterial, viral and fungal infections.

Rucotinib was developed by Incyte and is a first-in-class JAK1/JAK2 inhibitor. In November 2009, Novartis and Incyte reached a cooperation agreement to obtain the commercialization rights of Rucotinib outside the United States under the trade name Jakavi. Incyte is responsible for the development and commercialization rights of Rucotinib in the United States under the trade name Jakafi. Rucotinib tablets were first approved for marketing in the United States in November 2011, and are used to treat graft-versus-host disease (GVHD), myelofibrosis, and polycythemia vera.

The FDA approval is based on the results of a Phase III clinical project code-named TRuE-AD. The TRuE-AD project includes 2 randomized, double-blind, blank-controlled studies TRuE-AD1 (NCT03745638) and TRuE-AD2 (NCT03745651), both of which evaluated ruxolitinib cream in the treatment of mild to moderate atopic responses in adolescents and adults 12 years of age and older The safety and effectiveness of sexual dermatitis (AD).

The results of the study showed that after 8 weeks of treatment, in the TRuE-AD1 study, Rucotinib cream 0.75% BID (twice a day) and 1.5% BID dose group subjects IGA-TS (investigator's overall assessment of treatment success) probability They were 50.0% and 53.8%, while the blank control group was only 15.1%. In the TRuE-AD2 study, IGA-TS of subjects in the 0.75% BID and 1.5% BID dose groups of rucotinib were 39.0% and 51.3%, respectively, while the blank control group was only 7.6%.

After 8 weeks of treatment, TRuE-AD1 and TRuE-AD2 study rucotinib cream 0.75% BID, 1.5% BID and the control group had the same total incidence of emergency adverse events, which were 29.4%, 26.3%, and 33.6%, respectively. The incidence of serious adverse events was 0.8%, 0.6%, and 0.8%, respectively.

Incyte's financial report shows that Jakafi's US sales in 2020 will be 1.937 billion U.S. dollars. Novartis’s financial report shows that Jakavi’s 2020 sales outside the United States will be $1.339 billion.