New drugs for extra-use of plaque-type psoriasis! FDA approves Wynzora (calcium poisol/ dipropyl acid fentamisopine) cream!

24 July 2020 /PRNewswire/ -- MC2 Therapeutics is a commercial pharmaceutical company focused on developing new standards for localized treatment of chronic inflammation.
, the company announced that the U.S. Food and Drug Administration (FDA) has approved The Wynzora cream (calcium pobutan and glycemic acid fentamitol, w/w, 0.005%/0.064 percent) as a daily external therapy for the treatment of plaque-type psoriasis in adults up to 18 years of age.
recently, the company also submitted a marketing authorization (MAA) application for Wynzora cream to treat adult plaque-type psoriasis in the European Union.
Wynzora cream is a fixed-dose combination of calcium poise glycol and glyplyacid pythetamsone based on cream for local treatment of plaque-like psoriasis.
Wynzora cream is based on PAD technology, which uniquely makes calcium pometriphyand and dipropyosulprate thin rice pine stable in water-based formulations that are easy to use.
Phase III trials conducted at several clinical centers in the United States and the European Union, The Wynzora cream demonstrated a unique combination of compelling clinical efficacy, good safety and high convenience.
these characteristics of The Wynzora cream are expected to reduce treatment interruptions and improve overall patient satisfaction in localized treatment of plaque psoriasis in real-world settings.
medication, Wynzora is applied to the affected area once a day for 8 weeks, no more than 100 grams per week.
patients should stop treatment when plaque-type psoriasis is under control.
unless the doctor gives other instructions.
Wynzora cream is only used for the skin (partial).
FDA approval based on the results of a Phase III trial in the United States.
the trial compared the Wynzora emulsion with the positive control drug Taclonex external suspension (calpnosic and glycolic acid tummysone, w/w, 0.005%/0.064%). A total of 794 patients in the
trial were randomly grouped, with the main outcome being the proportion of patients who were confirmed to have successful treatment by the PGA in the eighth week of treatment, defined as the PGA improving at least 2 levels from the baseline to reaching "complete removal" or "almost complete removal" of the skin loss.
data show that the Developmentzora treatment group had a 14.6% increase in PGA success rates compared to the Taclonex control group (95% CI: 7.6%, 21.6% ;p 0.0001).
in addition, from baseline examination to the fourth week of treatment, the proportion of patients with itchreduction reduction in the Wynzora group was significantly higher than that of the drugless excipient group (60.3% vs 21.4%) as the 11-point peak itching numerical lysage scale (NRS) improved by at least 4 points. "Wynzora cream is a new type of local treatment for plaque-type psoriasis, providing a unique combination of efficient, safe and excellent treatment convenience in a single product," said Dr. Linda Stein Gold, lead researcher on
the study and director of clinical research on dermatology at Henry Ford Health System in Detroit, Michigan. "The FDA approval marks an important milestone for patients with plaque dandruff disease," said Jesper J. Lange, CEO of
MC2.
our PAD technology allows us to develop the ® Ofera cream without compromise.
it drives the convincing efficacy and safety data of The Wynzora ® cream, and turns it into an impact on patients with a convenient formula that enables patients to continue treatment within minutes of routine treatment in the morning.
it gives patients back control of treatment and daily life.
" () Original origin: MC2 Therapeutics Announces U.S. Food and Drug Administration approval of Wynzora Cream (calcipotriene and betamethasone dipropionate w/w 0.005%/0.064%) For Adults with Plaque Psoriasis.