Incyte’s topical Jakafi draws long-term side-effect caution, says GlobalData

Following Incyte’s announcement about positive topline Phase III results for topical Jakafi (ruxolitinib) in the treatment of mild-to-moderate atopic dermatitis (AD);

Reynald Castaneda, Pharma Writer for the Investigative News team at GlobalData, a leading data and analytics company, discusses his reporting:

“While experts I interviewed prior to Incyte’s announcement were optimistic about the Phase III’s success liklihood, they were regardless wary of long-term safety risks. While the therapy tested is a cream formulation, there is still a possibility of systemic absorption. This could be potentially problematic for chronic patients given that Jakafi has an immunosuppressant mechanism of action.

“Further inflaming absorption concerns is the fact that the Phase III trials are recruiting patients with a maximum 20% body surface area (BSA), which some experts said could be too high. Nonetheless, if topical Jakafi reaches the market, experts noted it could secure first-line uptake in patients who are not ideal for standard of care topical steroids, as well as for use before later-line calcineurin inhibitors and Pfizer’s phosphodiesterase-4 inhibitor Eucrisa.

“Topical Jakafi is expected to a make upward of a $1bn in peak sales. It is in two Phase III trials, with the company reporting results from the TRuE-AD2 trial yesterday and saying results from the second pivotal study, TRuE-AD1, are expected later this quarter.”

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