Scrip is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

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
UsernamePublicRestriction

Sanofi Stunned As FDA Says No To CAD Drug Sutimlimab

Deficiencies At Third-Party Manufacturing Facility

Executive Summary

The French major's hopes for launching its rare blood disorder drug sutimlimab soon have been scuppered by a complete response letter from the FDA after inspecting a third-party facility responsible for making the first-in-class therapy.

You may also be interested in...



Quick Listen: Scrip’s Five Must-Know Things

Join us for a brief audio tour around the past week's key developments in the global biopharma industry, in this podcast version of Scrip's Five Must-Know Things.

Sanofi Nabs Priority Review For New Pompe Drug

The French drugmaker's follow up to Myozyme – avalglucosidase alfa – is in line for a potential US approval by May next year after the US FDA agreed to a speedy review of the enzyme replacement therapy, unlike its European counterparts.

Sanofi Hampered By Fitusiran Clinical Hold In Hemophilia

The French major stressed to Scrip that patients enrolled in its fitusiran clinical trials often have other health issues and various co-morbidities, so it is too early to know if the adverse events are treatment-related.

Related Content

Topics

Related Companies

UsernamePublicRestriction

Register

OM005385

Ask The Analyst

Please Note: Click here for more information on the Ask the Analyst service.

Your question has been successfully sent to the email address below and we will get back as soon as possible. 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