Genzyme: FDA will review Lemtrada, its drug candidate for relapsing MS
Genzyme, now a Cambridge-based unit of French drug giant Sanofi SA., said Monday that the US Food and Drug Administration will review its application for Lemtrada, its drug candidate for the treatment of relapsing multiple sclerosis, or RMS.
Sanofi bought Genzyme for $20.1 billion in 2010.
Under its new corporate parent, Genzyme, long known as a maker of treatments for rare diseases, has mounted an effort to enter the lucrative, and broader, market for multiple sclerosis drugs, which is estimated at about $13 billion a year worldwide, it was noted in a recent Globe story that referenced Lemtrada.
Lemtrada is aimed at patients with relapsing multiple sclerosis; it is administered intravenously once a year for five days the first year of use, and for three days the next year.
In a press release
, Genzyme said it expects FDA action on the application in the second half of 2013.
Genzyme said it has already submitted its marketing authorization application for Lemtrada to European regulators, and the review process there is underway.
Last August, Genzyme suffered a setback when the FDA asked it to change the way it presents clinical data and resubmit an application it filed in June for approval of Lemtrada.
Projected revenue from Lemtrada, which will compete with several other multiple sclerosis drugs already being sold, became a major sticking point in 2010 when executives negotiated Sanofi’s takeover of Genzyme, another Globe story reported.
Ultimately, the parties agreed to award Genzyme stockholders a tradeable security, called a contingent value right. Its price will depend on whether Lemtrada is approved by regulators and meets certain sales targets in coming years, that story said.
“Genzyme is making a difference for people living with MS and realizing its vision of being leaders in MS,” Genzyme president and chief executive David Meeker, M.D., said in a statement.
“The acceptance of the Lemtrada file in the US marks another important milestone in bringing this potentially transformative therapy to MS patients,” he added.Chris Reidy can be reached at firstname.lastname@example.org.