Pink Sheet 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


Genzyme Will Appeal Lemtrada “Complete Response” After FDA Seeks More Trials

This article was originally published in The Pink Sheet Daily

Executive Summary

Rater-blinded design for multiple sclerosis claim netted an approval in Europe but a rejection by FDA, which was concerned about bias related to open label studies.

You may also be interested in...

Genzyme Nabs Elusive Lemtrada Approval, But As Third-Line MS Therapy

FDA says therapy for relapsing multiple sclerosis should be reserved for patients who fail two or more other MS treatments; REMS includes four-year follow up.

On The Offense: Sanofi Suits Up For A Game Change

Having exited its patent cliff and advanced several drugs into late-stage development, Sanofi is moving into a new commercial-centric phase. Its future looks bright, but success is not guaranteed.

NICE's Unrestricted MS Indication For Lemtrada Could Boost It Ahead Of Rivals

Though not totally convinced about long-term effectiveness and patient adherence, NICE's decision not to restrict Lemtrada's indication could place it ahead of Gilenya and Tysabri for relapsing-remitting multiple sclerosis.

Related Content


Related Companies

Latest Headlines
See All



Ask The Analyst

Ask the Analyst is free for subscribers.  Submit your question and one of our analysts will be in touch.

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