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.
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.
After a scathing staff review, Sanofi walked away from an FDA panel with mixed messages on its long-delayed multiple sclerosis drug, as agency advisers said the injection wasn't too risky to approve but took issue with the drugmaker's trial design.
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."
Sanofi's multiple sclerosis drug Lemtrada may be too dangerous to warrant FDA approval, agency staff said, potentially damning news for an injection that has slogged through 25 years of back-and-forth development.
Sanofi now has not one, but two, big multiple sclerosis launches to get under way in Europe. Two weeks after nabbing EU approval for its new MS pill Aubagio, Sanofi got regulatory clearance for Lemtrada.
It was a very, very big week in Europe for drugmakers. The European Committee for Medicinal Products for Human Use (CHMP) recommended 10 drugs for approval, including two biosimilars, it said today.
Sanofi's Genzyme got a double dip of good news Friday for its expansion in the multiple sclerosis market. First Europe's drug regulator gave a nod to Lemtrada for treating the disease. Then, as a bonus, it gave a designation to Genzyme's potential blockbuster Aubagio that will keep its patent protected longer.
Lemtrada, Sanofi's "new" drug for multiple sclerosis, helps demonstrate just how plagued the drug-development process can be, with a series of false starts and sudden stops as it was handed off from one company to the next. Today, Reuters ' Ben Hirschler chronicled the 25-year R&D odyssey, which is expected to be capped soon with a European approval followed soon after by an FDA decision.
Genzyme executives today rolled out positive data from a one-year extension study of its pivotal Phase III trial that gives the company some boasting rights for a drug that demonstrated a durable response in most patients.