DANSK BIOTEK organizes four major plenary meetings for our members throughout the year to increase our members' knowledge regarding specific biotech topics and to facilitate networking. The events usually take place in February, May, September and November.

We also organize approximately four "saloon" meetings annually. They are small, intimate, "meet the expert" meetings with typically 6-20 participants advocating more in-depth discussion and knowledge-sharing on specific themes.

22 Nov 2019

MC2 Therapeutics Announces FDA Acceptance of its New Drug Application for Wynzora™ Cream for Treatment of Plaque Psoriasis

COPENHAGEN, Denmark, November 21, 2019 / B3C newswire / — MC2 Therapeutics, an emerging pharmaceutical company focused on novel PAD™ Technology-based topical therapies for chronic inflammatory conditions, today announced that the U.S. Food and Drug Administration (FDA) has accepted for review the New Drug Application (NDA) for Wynzora™ Cream. MC2 Therapeutics is seeking marketing approval for Wynzora™ Cream for the treatment of plaque psoriasis. The FDA has set July 20th, 2020 as the Prescription Drug User Fee Act (PDUFA) action date.

MC2 Therapeutics’ NDA for Wynzora™ Cream is comprised of extensive quality, non-clinical and clinical data. Specifically, data from the pivotal phase 3 trial demonstrated that Wynzora™ Cream treatment has a substantial and statistically significantly greater efficacy compared to Taclonex® Topical Suspension (“Taclonex®”) based on treatment success defined as a minimum two-point decrease in the Physician Global Assessment (PGA) score to clear or almost clear disease (40.1% versus 24.0%, p < 0.0001).

“We are very proud of the overall clinical profile of Wynzora™ Cream and look forward to continuing our interaction with the FDA during the NDA review”, said Jesper J. Lange, President & CEO of MC2 Therapeutics and added “In parallel we will continue our efforts to ensure widespread patient access to Wynzora™ Cream pending approval”.

 

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