Phase III long-term study confirms safety of Astellas fezolinetant

12 October 2022
astellas_big

Japanese pharma major Astellas (TYO: 4503) today released positive 52-week results from the Phase III SKYLIGHT 4 clinical study evaluating the safety and tolerability of fezolinetant, an investigational oral, nonhormonal compound being studied for the treatment of moderate to severe vasomotor symptoms (VMS) associated with menopause.

The full results will be featured in an oral presentation October 13 at The North American Menopause Society Annual Meeting.

SKYLIGHT 4 results demonstrate the 52-week safety and tolerability of fezolinetant 30mg and 45mg once daily. Safety analyses demonstrated that both endometrial hyperplasia and endometrial malignancy were within pre-specified limits for fezolinetant-treated patients; reported treatment-emergent adverse events (TEAEs) were generally mild or moderate in severity; and headache and COVID-19 were the most common TEAEs, with similar incidences for fezolinetant and placebo. The frequency of elevated liver enzymes was low across groups, and elevations were generally asymptomatic, isolated, transient and resolved on treatment or soon after study drug discontinuation.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK



Today's issue

Company Spotlight





More Features in Pharmaceutical