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

Sanofi Posts More Positive Olipudase Alfa Data As Approval Decisions Loom

First Potential Therapy For Rare Lysosomal Storage Disease

Executive Summary

Ahead of a PDUFA date of 3 July, Sanofi has added to the body of clinical evidence supporting olipudase alfa as a treatment for acid sphingomyelinase deficiency (ASMD), a rare, progressive and potentially life-threatening disease with no approved therapies.

You may also be interested in...



Keeping Track: Orphan Drugs Aplenty At US FDA, From Pyrukynd Approval To Adagrasib Standard Review

The latest drug development news and highlights from the Pink Sheet’s US FDA Performance Tracker

Sanofi Unruffled By JAK Threat To Dupixent

CEO Paul Hudson tells Scrip that in an atopic dermatitis market that has a standard of care like Dupixent, "it's hard to justify the role of a JAK unless somebody has, frankly, failed everything else."

Sanofi ‘Strongly Disagrees’ With EMA Rejection Of NAS Status For Nexviadyme

Sanofi argues that the European Medicines Agency applies a narrow interpretation of its new active substance principles which is not appropriate for biological therapies, and that the regulator fails to consider the challenges of conducting clinical research in rare diseases.

Related Content

Topics

Related Companies

Latest News
UsernamePublicRestriction

Register

SC145869

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