The ID Pipeline: FDA Activity From the Week of December 29, 2019
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of December 29, 2019.
Here is a look at infectious disease-related US Food and Drug Administration (FDA) news from the week of December 29, 2019.
Chembio Anticipates FDA Approval of DPP HIV-Syphilis Test During Q1 2020
Chembio Diagnostics, Inc. has provided an update on its premarket approval application submission to the FDA for the DPP HIV-Syphilis System, which includes the DPP HIV-Syphilis test and DPP Micro Reader. The firm anticipates FDA approval of the DPP HIV-Syphilis System in the first of 2020.
The DPP HIV-Syphilis System is a 15-minute, single use screening test for the detection of antibodies to HIV types 1 and 2 as well as Treponema pallidum, the bacteria which causes syphilis. The test uses a 10 microliter sample of fingerstick of whole blood, venous whole blood, or plasma. It is highly specific and sensitive, can be stored at room temperature, and has a shelf life of up to 24 months.
Read the full press release here.
Novan Announces Top-Line Efficacy Results From Phase 3 Trials of SB206 for Molluscum Contagiosum
Novan, Inc. has announced top-line efficacy results from its phase 3 B-SIMPLE program with SB206 for treatment of molluscum contagiosum. SB206 did not achieve statistical significance for the primary endpoint in B-SIMPLE1 or B-SIMPLE2, but several sensitivity analyses are supportive and consistent across studies in support of a possible path forward.
B-SIMPLE2 was statistically significant for prespecified sensitivity analyses, and the firm intends to use the results as a confirmatory trial for the New Drug Application Submission.
Both trials are ongoing and awaiting 24-week safety data.
Read the full press release here.
