On Friday, the FDA accepted Sanofi's supplemental application for its once-rejected multiple sclerosis treatment Lemtrada for consideration, and a 6-month review period follows.
Sanofi 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.
Sanofi felt the sting of lost sales potential when the FDA nixed its multiple sclerosis treatment Lemtrada in December. But the EU sees things a bit differently, and now a new nod from Britain's cost watchdog has unlocked some new top-line potential.
Late last year, Sanofi's MS drug Lemtrada was slapped down by the FDA. Sanofi investigators now tell FierceBiotech that two years after patients in Phase III studies received their last course of treatment, many are still clearly benefiting from the drug.
Sanofi investors are fed up with disappointing news on the multiple sclerosis drug Lemtrada. Vaunted as a potential blockbuster, the drug hasn't even made it to market in the U.S. Now, some investment funds are suing the French drugmaker, saying executives talked up Lemtrada in public--and kept bad news from the FDA private.
Sanofi is walking away from any plans to appeal the FDA's emphatic rejection of the multiple sclerosis drug Lemtrada, at least for now. But rather than launching the added trial that the FDA demanded ahead of any possible approval, the company thinks it has a shot at answering the FDA's concerns with a new application.
After a December flip-flop, the word from NICE on Sanofi's Aubagio is now final: The British cost watchdog has recommended the multiple sclerosis pill for use in Britain's National Health Service, tallying a victory for an MS franchise that has seen some recent ups and downs.
Sanofi intends to appeal the FDA's denial of Lemtrada, its multiple sclerosis drug that was a key reason it paid $20.1 billion to buy Genzyme two years ago. But will the company invest more money in the drug, given that after three more years of trials it will be far behind competitors?
Sanofi has been slammed against the regulatory wall at the FDA, picking up a stinging rejection of its multiple sclerosis drug Lemtrada with orders to go back to the clinic for a major round of new trial work if the company ever expects to get the drug over the U.S. finish line at some point.
Thursday, Sanofi's multiple sclerosis drug Lemtrada was stymied by the U.K.'s cost-effectiveness gatekeeper, which asked for more data on the med before it could determine its worth. But just one day later, the regulatory body gave Sanofi's MS franchise a boost: It has recommended Aubagio, its oral treatment, for use in Britain's National Health Service.