French drug major Sanofi (Euronext: SAN) and subsidiary Genzyme have reported results from pivotal studies - CARE-MS I and CARE-MS II showing that the multiple sclerosis drug Lemtrada (alemtuzumab) was significantly more effective at reducing annualized relapse rates than the comparator Rebif ((77.6% versus 58.7%, p<0.0001), and about 65% of patients on Lemtrada were relapse-free at two years compared to 47% on Rebif (p<0.0001).
In addition, in CARE-MS II, accumulation of disability was significantly slowed in patients receiving Lemtrada versus Rebif (interferon beta-1a). Furthermore, data indicated that patients treated with Lemtrada were significantly more likely to experience improvement in disability scores than those given Rebif suggesting a reversal of disability in some patients.
The company also released results from a Phase II clinical trial (n=183) showing that SAR236553/REGN727, under development with the USA’s Regeneron Pharmaceuticals (Nasdaq: REGN) administered in a 1ml injection every two weeks plus atorvastatin achieved a mean reduction of 73% in LDL-C compared to a mean reduction of 17% for patients who switched to atorvastatin 80mg alone (p<0.001) after eight weeks. The most common adverse events were headache, dizziness and diarrhea. These findings in patients with primary hypercholesterolemia were published in the October 31 issue of the New England Journal of Medicine.
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