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Novan Announces FDA Has Granted Type C Meeting For SB206, Provides Additional 12-Week Efficacy And Safety Data

Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today provided an update on several aspects of its Phase 3 B-SIMPLE program (B-SIMPLE1 and B-SIMPLE2).   Novan has been granted a Type C

Benzinga · 02/06/2020 13:34

Novan, Inc. (“the Company” or “Novan”) (NASDAQ:NOVN) today provided an update on several aspects of its Phase 3 B-SIMPLE program (B-SIMPLE1 and B-SIMPLE2).  

Novan has been granted a Type C meeting with the U.S. Food and Drug Administration (“FDA”) on April 1, 2020. The Type C Meeting is to seek FDA feedback on the proposal to conduct one additional, well-controlled confirmatory study of SB206 to support a future New Drug Application (“NDA”).

In the Company’s Phase 3 B-SIMPLE program with SB206 for the treatment of molluscum contagiosum, the last subject completed their final visit as part of the ongoing safety evaluation through Week 24. Top-line efficacy results from this program were announced on January 2, 2020, and full efficacy and safety data, including data from the safety evaluation through Week 24, are targeted to be available in March 2020.

The safety profile of SB206 through the Week 12 visit was found to be favorable. Adverse events experienced in the B-SIMPLE program were primarily mild to moderate and the only treatment emergent adverse events (TEAE) reported in greater than 5% of subjects in the SB206 treatment arm were application site pain and application site erythema. There were no treatment-related serious adverse events reported in B-SIMPLE1 or B-SIMPLE2.