The US Food and Drug Administration (FDA) recently granted fast-track status to Genzyme Corporation’s (GENZ) alemtuzumab, which is being developed for the treatment of multiple sclerosis. Fast-track status was granted for the treatment of patients with relapsing-remitting forms of multiple sclerosis.
The FDA assigns fast-track status to products that are being developed for the treatment of serious or life-threatening diseases. Under this designation, a company can file the New Drug Application (NDA) for the candidate on a rolling basis and can also seek priority review status. This helps speed up the review process.
Alemtuzumab is currently in two pivotal phase III studies that should report results in 2011. While one study (CARE-MS I) is comparing alemtuzumab to Merck KGaA’s Rebif in patients with treatment-naive early, active relapsing-remitting multiple sclerosis (RRMS), the second study (CARE-MS II) is comparing alemtuzumab to Rebif in RRMS patients who relapsed during treatment.
Earlier this year, Genzyme had presented encouraging follow-up phase II results on alemtuzumab. The study, which compared alemtuzumab with Rebif, was conducted in treatment naïve patients suffering from early, active RRMS.
Results showed that about 71% of patients treated with alemtuzumab remained free of the disease even three years after treatment compared to 35% in the Rebif arm. Moreover, about 91% of patients in the alemtuzumab arm (versus 68% in the Rebif arm) were free of sustained accumulation of disability. Genzyme reported that 77% of the patients treated with alemtuzumab remained relapse-free compared to 49% in the Rebif arm.
Positive results from the ongoing phase III studies would be a major boost for Genzyme and would allow Genzyme to provide multiple sclerosis patients with a new treatment option. The multiple sclerosis market is dominated by players like Biogen Idec’s (BIIB) Tysabri and Avonex, Teva’s (TEVA) Copaxone, and Rebif.
Alemtuzumab is currently available for the treatment of B-cell chronic lymphocytic leukemia (B-CLL) under the trade name Campath.
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