Due to its safety profile, the use of Lemtrada should generally be reserved for patients who have had an inadequate response to two or more drugs indicated for the treatment of MS.
Lemtrada has two annual treatment courses, the first is administered via intravenous infusion on five consecutive days, while the second is administered on three consecutive days, 12 months later.
North Central Neurology Associates founder Christopher LaGanke said: "As an investigator in the Phase III clinical development program with firsthand experience, I have been awaiting the ability to prescribe Lemtrada to patients in my practice who could potentially benefit from this treatment.
"Following REMS training and certification, I am excited that I was able to become the first physician to initiate patient treatment in the United States."
In November, the FDA approved Lemtrada based on two pivotal randomized Phase III open-label rater-blinded studies comparing treatment with Lemtrada to Rebif in patients with relapsing remitting MS who were either new to treatment (CARE-MS I) or who had relapsed while on prior therapy (CARE-MS II).
In CARE-MS I, Lemtrada was significantly more effective than interferon beta-1a at reducing annualized relapse rates and in CARE-MS II, the drug was significantly more effective than interferon beta-1a at reducing annualized relapse rates, and accumulation of disability was significantly slowed in patients given Lemtrada vs. interferon beta-1a.
Genzyme head of Multiple Sclerosis business Bill Sibold said: "Since approval, we have been singularly focused on providing access as quickly as possible for those patients awaiting Lemtrada by ensuring drug availability, completing required REMS training and certifications, and establishing appropriate patient support."
Image: Genzyme global headquarters in Cambridge, Massachusetts, US. Photo: courtesy of Tim Pierce.