Genzyme Corporation and Bayer HealthCare Pharmaceuticals
- Administered in one course yearly by intravenous infusion over three-to-five consecutive days. The drug is approved for the treatment of B-cell leukemia and targets T cells, B cells, and macrophages.
- The drug was granted Fast Track status by the FDA in June 2010, which will expedite its review.
- The CAMMS223 Phase II study of 334 individuals with early, active RRMS compared Campath to high-dose Rebif (44 mcg) in RRMS. In a three-year safety and efficacy trial, Campath was more effective than interferon beta-1a at reducing the relapse rate and the risk for 60-month sustained accumulation of disability in patients with RRMS. In fact, the annualized relapse rate in patients on Campath was 0.1, which means one attack every 10 years. This is the lowest relapse rate ever reported for an MS drug. More than 50 percent of the Campath-treated patients actually improved.
- In a fourth-year extension study of 334 individuals who participated in the original CARE MS1 and CARE MS2 studies, Campath yielded a 73-percent reduction in risk for sustained accumulation of disability versus a 68-percent reduction for individuals taking interferon beta-1a. At year four, 77 percent of Campath-treated patients were relapse-free, compared with 49 percent of patients taking interferon beta-1a.
- Side effects include a reduction in blood clotting, thyroid disorders, infusion reactions, and infection. Patients need to be monitored closely due to risk of significant toxicities.