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| Sanofi CEO Chris Viehbacher |
Sanofi ($SNY) has resubmitted Lemtrada, its long-in-development multiple sclerosis treatment, for FDA approval, gambling that a new analysis of the same data will sway regulators in a second review.
The agency has accepted Sanofi's supplemental application, the company said, thus kicking off a 6-month review period with a final decision expected in the fourth quarter of this year.
In its rejection letter, handed down in December, the FDA contended Sanofi had not adequately demonstrated that Lemtrada's strengths outweighed its weaknesses, taking serious issue with the design of a Phase III study in patients with relapsing-remitting MS. And regulators made it clear that the once-a-year treatment wouldn't be approvable until Sanofi conducted one or more additional Phase III trials.
But that's just not an option, Sanofi CEO Chris Viehbacher has said. After scrapping plans to appeal the FDA's decision, the company is instead supplementing its first application with fresh analysis, extended clinical results and "additional information to specifically address issues previously noted by the FDA," Sanofi said. The resubmission comes on the heels of "constructive discussions" with the agency, according to the company.
However, even if things work out on Lemtrada's second go at U.S. approval, analysts have dialed back peak sales estimates far below the drug's once-sky-high promise now that its many developmental delays have allowed rivals to creep in and grab MS market share. Oral therapies like Biogen Idec's ($BIIB) Tecfidera and Novartis' ($NVS) Gilenya lead the way among a new class of treatments for the disease, and most analysts figure Lemtrada, if approved, would be used only in advanced cases of MS.
Back in 2011, the drug was a major bargaining chip in Genzyme's prolonged negotiations with Sanofi, helping the Boston biotech land a $20 billion price tag. After 25 years in development, the drug was already approved to treat B-cell chronic lymphocytic leukemia when Genzyme first got hold of it in 2004, but, seeing a more lucrative market in MS, the biotech took it off the cancer market and got to work on a new indication.
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