Genzyme to Resubmit Lemtrada Application for FDA Review - - BioPharm International

ADVERTISEMENT

Genzyme to Resubmit Lemtrada Application for FDA Review



Sanofi and its subsidiary Genzyme reported that the company plans to resubmit its supplemental Biologics License Application (sBLA) seeking approval of Lemtrada (alemtuzumab) for the treatment of relapsing forms of multiple sclerosis. The resubmission will provide information to specifically address issues noted by the FDA in its Dec. 27, 2013 Complete Response Letter.

Genzyme had previously announced its intention to appeal the FDA's Complete Response Letter. As a result of the planned resubmission, the company does not expect to pursue an appeal at this time.

Source: Sanofi

blog comments powered by Disqus

ADVERTISEMENT

ADVERTISEMENT

PDA Announces Technical Report on Drug Shortages
September 9, 2014
European Commission Approves RoACTEMRA for Treatment of RA
September 9, 2014
DPT Laboratories Acquires Media Pharmaceuticals' Lakewood Facilities
September 5, 2014
Merck KGaA Breaks Ground on Facility in China
September 5, 2014
FDA Releases Guidance Electronic Submission of Lot Distribution Reports
September 5, 2014
Author Guidelines

Click here