Scrip is part of Pharma Intelligence UK Limited

This site is operated by Pharma Intelligence UK Limited, a company registered in England and Wales with company number 13787459 whose registered office is 5 Howick Place, London SW1P 1WG. The Pharma Intelligence group is owned by Caerus Topco S.à r.l. and all copyright resides with the group.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By

UsernamePublicRestriction

Incyte's Jakafi 1st drug OK'd in polycythemia vera

This article was originally published in Scrip

Executive Summary

One day ahead of its Prescription Drug User Fee Act action date, Incyte's oral JAK1/JAK2 inhibitor Jakafi (ruxolitinib) won the FDA's approval in patients with polycythemia vera (PV) who have had an inadequate response to or are intolerant of hydroxyurea – the first drug to gain that indication in the US.

You may also be interested in...



Keeping Track: CDER Approves Its First Two Novel Agents Of 2019

The latest drug development news and highlights from our US FDA Performance Tracker.

Syros’ 98% Solution For Genomic Medicine

Emerging Company Profile: Coming off its first partnership and a $43.2m IPO, Syros looks ahead to data later this year for its first two clinical candidates, both first-in-class agents that regulate gene expression.

Incyte Will File Jakafi For Acute GVHD In US Based On Phase II Success

The JAK1/2 inhibitor may add an indication for acute graft-versus-host disease, though based on a single, open-label Phase II trial that showed a 55% response rate in a high-mortality indication.

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

SC027141

Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

Thank you for submitting your question. We will respond to you within 2 business days. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts

Cancel