ARTICLE | Product Development
Vertex’s analgesic heads for submission; plus the latest from Sarepta in DMD, Lilly in hearing loss, and more
By Lauren Martz, Executive Director of Biopharma Intelligence, and Paul Bonanos, Director of Biopharma Intelligence
January 31, 2024 1:18 AM UTC
New acute pain data are likely to support regulatory approval of Vertex’s non-opioid analgesic, but a miss on a secondary endpoint does raise questions about the extent to which payers will cover the therapy.
Tuesday’s readout showed that VX-548 from Vertex Pharmaceuticals Inc. (NASDAQ:VRTX) met the primary endpoints in two Phase III studies, significantly improving pain scores compared with placebo in patients who had undergone abdominoplasty or bunionectomy. The company is aiming to submit an NDA to FDA in mid-2024, with approval possible the following year…