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

With Duchenne Filing Due, Santhera Moves Vamorolone Into Becker Muscular Dystrophy

Rare Disease Trial Receiving FDA Funding

Executive Summary

Santhera is bouncing back after a Duchenne drug failure two years ago with idebenone, and is looking to gain approval of vamorolone in this indication as well as the much rarer Becker muscular dystrophy.

You may also be interested in...



Santhera Finalizes Vamorolone Filings And Now Seeks Funds

The Swiss biotech is hoping that its Duchenne muscular dystrophy prospect, vamorolone, will get on the FDA fast track to approval but acknowledges that getting more funds is an urgent priority to prepare for a potential US launch.

Sarepta Pursues DMD Gene Therapy Accelerated Approval To Be First To Market

Sarepta has experience pursuing accelerated approvals in the US for Duchenne muscular dystrophy therapies, but with a costly gene therapy will payers require data from a controlled Phase III study?

Italfarmaco To Seek Givinostat Approvals After Phase III Success In DMD

Italfarmaco’s HDAC inhibitor helped ambulatory Duchenne muscular dystrophy patients climb stairs faster than non-treated boys while Capricor’s cell therapy improved upper limb function in non-ambulatory patients.

Related Content

Topics

Related Companies

Latest Headlines
See All
UsernamePublicRestriction

Register

SC146921

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