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


Shire Withdraws Replagal BLA Rather Than Conduct Lengthy Trials – Updated

This article was originally published in Pharmaceutical Approvals Monthly

Executive Summary

Replagal seemed destined for quick approval – the enzyme replacement therapy was already distributed free of charge to U.S. patients in response to short supples of Genzyme’s Fabrazyme. But FDA has signaled otherwise, and Shire doesn’t think Replagal warrants the effort.

You may also be interested in...

Replagal Advisory Committee Will Include Closed Door Session On Manufacturing

FDA’s Cardiovascular and Renal Drugs Advisory Committee will assess Shire biologics’ BLA for the Fabry disease therapy, which already is available in the U.S. due to shortages of competitor Fabrazyme, during a March 27 meeting.

Genzyme’s Framingham Plant Clears FDA; Restoring Full Supply Could Take All Year

The subsidiary of Sanofi long has pegged opening of additional plant as critical to restoring full production of Fabrazyme, which has been rationed to Fabry disease patients since a manufacturing interruption in 2009.

Genzyme Plant Cleanup Brings Temporary Halt To Fabrazyme, Cerezyme Production

Plagued by a virus, the biotech hopes to have Allston Landing facility back in operation by late July, but warns of short-term drug shortages.


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