Based on the FDA’s positive feedback, we believe the Phase III ENHANCE trial design (as detailed below) gives a reasonable and achievable path for regulatory approval for use in symptomatic COPD patients as a maintenance therapy. The decision to evaluate ensifentrine as a monotherapy and as an add-on to a single standard-of-care bronchodilator treatment (LAMA or LABA) is logical, and allows for a broad label. We note that ensifentrine has demonstrated clinically meaningful and statistically sign ....
14 May 2020
FDA End of Phase II meeting gives a clear path for ensifentrine
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FDA End of Phase II meeting gives a clear path for ensifentrine
Verona Pharma plc Sponsored ADR (VRNA:NAS) | 0 0 0.0%
- Published:
14 May 2020 -
Author:
Edward Thomason -
Pages:
4
Based on the FDA’s positive feedback, we believe the Phase III ENHANCE trial design (as detailed below) gives a reasonable and achievable path for regulatory approval for use in symptomatic COPD patients as a maintenance therapy. The decision to evaluate ensifentrine as a monotherapy and as an add-on to a single standard-of-care bronchodilator treatment (LAMA or LABA) is logical, and allows for a broad label. We note that ensifentrine has demonstrated clinically meaningful and statistically sign ....