Indication extensions recommended for nine drugs by CHMP

1 February 2019
ema_big

At its January 28-31 meeting, the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP), as well as giving opinions on six novel medicines, it recommended the extension of indications for nine further drugs, as follows:

Forxiga and its duplicate Edistride (dapagliflozin), from AstraZeneca (LSE: AZN), as an adjunct treatment to insulin in the form of a tablet for certain patients with type 1 diabetes mellitus.

Hemlibra (emicizumab) from Roche (ROG: SIX), for routine prophylaxis of bleeding episodes in adults and children with severe hemophilia A (congenital factor VIII deficiency, FVIII <1%) without factor VIII inhibitors. The CHMP has also recommended that Hemlibra can be used at multiple dosing options (once weekly, every two weeks, or every four weeks) for all indicated people with hemophilia A, including those with factor VIII inhibitors.

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 Pharmaceutical