Tag:

Lemtrada

Latest Headlines

Latest Headlines

The bright side to Sanofi's Lemtrada delay? Its support-to-sell marketing plan

Sanofi's Genzyme has found a silver lining to last winter's FDA snub of Lemtrada. For starters, Genzyme is fielding an extensive provider-and-patient support program, developed based on feedback from a range of stakeholders.

Sanofi tags newly OK'd MS drug Lemtrada at $158K, ready to tout head-to-head Rebif data

Sanofi finally has its FDA approval for Lemtrada. The multiple sclerosis drug, previously rejected by the agency, will hit the market after a trio of new oral treatments. It will come with a boxed warning and faces tight controls on prescribing and distribution.

FDA will hear Sanofi's second plea for Lemtrada approval

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's new MS med scores a spot on U.K.'s NHS formulary

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.

Sanofi misled investors with rosy Lemtrada predictions, lawsuit alleges

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's MS pill Aubagio wins final thumbs-up from U.K. cost-effectiveness watchdogs

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.

FDA says nada to Lemtrada; will Sanofi be willing to invest in additional trials?

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?

The day after its Lemtrada snub, NICE blesses Sanofi's Aubagio

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.

Sanofi's MS drug Lemtrada tripped up again, this time in U.K.

Less than a month ago, Sanofi's multiple sclerosis treatment Lemtrada ran into problems with FDA staffers who were unconvinced of the drug's safety and efficacy. Now, it looks as if the U.K. may share some of those doubts. Its cost-effectiveness gatekeeper has asked the French pharma for more data, giving the company just over a month to submit the supplementary information.

FDA staffers throw cold water on Sanofi's Lemtrada hopes

If you're a drug developer, which 6 words do you never, ever want to see in an FDA review of a potential new product? The 6 words applied to Sanofi's multiple sclerosis treatment Lemtrada: "serious and potentially fatal safety issues."