Gilead to file for US approval of filgotinib this year

3 July 2019
gilead-big

US biotech Gilead Sciences (Nasdaq: GILD) and Belgium-based partner Galapagos (Euronext: GLPG) both saw their shares go up by close of trading yesterday, after Gilead provided an update about the investigational oral, selective JAK1 inhibitor, filgotinib.

Gilead said that, at a recent pre-New Drug Application (NDA) meeting with the Food and Drug Administration, it discussed the Phase III FINCH studies, as well as the ongoing Phase II MANTA safety study assessing semen parameters with filgotinib treatment in men with moderately to severely active ulcerative colitis or Crohn's disease.

As a result of this discussion, a path forward has been established to submit the NDA for filgotinib as a treatment for rheumatoid arthritis in 2019, Gilead noted.

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

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology