Adalvo confirms a successful pivotal BE outcome for Dimethyl Fumarate 120mg gastro-resistant tablets under fed conditions, advancing its position in supporting partner access to this high-value dermatology asset.
Dimethyl Fumarate is an oral therapy for moderate to severe plaque psoriasis, a chronic skin condition requiring long-term treatment. Based on the reference brand Skilarence, the product generated global sales of around $30 million in 2024, according to IQVIA.
At this time, Adalvo is not seeing any competitor activity in the space, highlighting the opportunity for early market advantage.
Adalvo is preparing to file the DCP by June 2025, with regulatory strategy and dossier preparation on track to support launches in key EU markets.
This development complements Adalvo’s growing dermatology portfolio, which includes a range of high-value, partner-ready assets aimed at addressing unmet needs in chronic inflammatory skin conditions, such as but not limited to Apremilast Film Coated Tablets, Tapinarof, and Tacrolimus Ointment.
With a focus on complex development, regulatory precision, and global market execution, Adalvo continues to expand access to proven dermatology treatments through quality, innovation, and speed.
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