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

Japan-Specific Approval For Hemlibra In Acquired Hemophilia A

New Data Also In Mild/Moderate Disease

Executive Summary

Hemlibra receives new approval in Japan intractable disease indication, while positive Phase III results in mild/moderate disease hemophilia A will support a planned EU filing in this setting. 

You may also be interested in...



Novo Nordisk’s Concizumab Could Be First In New Class For Hemophilia

Phase III data for the drug showed strong efficacy among hemophilia A and B patients with inhibitors. The drug’s approval would help drive continued segmentation of the hemophilia market.

Sanofi Has One Hemophilia Winner On It Hands – But Fitusiran’s Fate Remains Unclear

Sanofi is hoping to have two paradigm-changing hemophilia drugs on the market by 2025 – but one of these, fitusiran, must first prove its safety and efficacy at a lower dose.

BioMarin Rolls Up Sleeves To Prepare For Roctavian’s EU Debut

The company plans to start in Germany with an outcomes-based payment model. But while a US FDA nod seems likely, analysts have been more cautious about calling US approval a done deal.

Related Content

Topics

Related Companies

Latest News
See All
UsernamePublicRestriction

Register

SC146720

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