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.
Sanofi's Genzyme unit isn't offering details about its sales of Kynamro, the rare disease treatment approved last January. It's not allowing its development partner, Isis Pharmaceuticals, to dole out specifics, either. What is certain, according to Isis COO Lynne Parshall, is that the launch started off slowly, and Genzyme has expanded its sales force to step up the pace.
Sanofi is doubling down on its RNAi development deal with Alnylam. The pharma giant says it will pay a hefty premium to buy up a 12% stake in the biotech, investing $700 million and greatly expanding its rights to Alnylam's lead drug along with a portfolio of current and prospective therapies.
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.
Sanofi's Genzyme snagged a 6-month priority review from the FDA for what could become the first oral treatment for Gaucher disease, a rare genetic disorder that causes abnormal fat buildup in cells, enlarging organs in the body.
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.
Gene-silencing expert Alnylam is $7 million richer thanks to some positive mid-stage results for its Genzyme-licensed RNA-interference candidate, and the Cambridge, MA, company is looking to be the first to market with the difficult-to-deliver class of treatments.
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.
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.
Genzyme's Framingham, MA, plant came to the rescue last year, supplying its rare-disease drug Fabrazyme that had been in short supply after viral contamination forced the closure of another facility in 2009. Now, the drugmaker intends to invest $80 million in downstream processing at the facility.