Microbio Co., Ltd. announced on the 12th that one of its medical device projects in development, the skin barrier repair cream MB107, has recently been withdrawn from its 510(k) application for topical cream due to a change in requirements by the U.S. Food and Drug Administration (FDA).
Microbio stated that it held a Pre-Submission meeting with the FDA last year regarding its medical device project. The FDA agreed that MB107 topical cream could be submitted for registration under the 510(k) regulatory pathway and received a response indicating exemption from clinical trials.
However, due to a change in FDA review requirements necessitating the submission of additional clinical trial data, Microbio has decided to follow the FDA's suggestion to withdraw the application. Upon completion of clinical trials and obtaining the necessary data later this year, MICROBIO plans to resubmit the 510(k) application to facilitate the final review process by regulatory authorities. The delay in application does not affect the business of MICROBIO Life Sciences.
MB107 is a novel drug targeting skin Microbiota as an AhR agonist indicated for plaque psoriasis and atopic dermatitis. Three batches of GMP production have already been completed, and in the first half of last year, Microbio received a positive response from the FDA after the Pre-Submission. Plaque psoriasis and atopic dermatitis are prevalent global skin diseases, with estimated global therapeutic opportunities reaching $22.7 billion and $14.2 billion respectively in 2022, projected to reach $47.7 billion and $27.7 billion by 2030.
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