Just weeks after Genzyme filed its application for Lemtrada as a new treatment for multiple sclerosis, regulators have handed the NDA back, telling the biologics arm of Sanofi ($SNY) that it needs to complete a rewrite before they can properly assess it.
Officially, Genzyme and Sanofi received a "refuse to file" letter after the FDA concluded that the subsidiary would need to modify its presentation. And the companies hastened to assure everyone that the FDA is not seeking an additional trial of the treatment, which represents Exhibit A in its case that it can win big new approvals for blockbuster drugs.
"We have had constructive dialogue with the FDA, and we are very confident in our ability to address the agency's request and resubmit rapidly", said Genzyme CEO David Meeker.
The regulatory action comes at a time Genzyme has been working to establish a reputation for itself as the savvy biologics player in Sanofi's worldwide operations, drawing attention to the big Boston R&D hub as operations in France are cut back. Lemtrada, a new name for Genzyme's Campath, has been expected to go on to a bright future as a competitor in the high-priced MS market. That's why just a week ago Genzyme announced plans to pull Campath to clear the way for the new treatment.
Sanofi is faring better in Europe, where regulators have already accepted the Lemtrada application.
- here's the press release
- read the Reuters article
Related Articles:
Sanofi pulls Campath to clear way for higher-priced Lemtrada
Sanofi presents parallel apps for blockbuster MS hopeful Lemtrada
Is Sanofi destined to be 'small player' in MS?