Who Owns Lemtrada?

Alemtuzumab's history in MS predates the Lemtrada brand. The compound was originally developed as Campath (alemtuzumab) for the treatment of B-cell chronic lymphocytic leukemia (CLL), where it was approved by the FDA in 2001. Researchers at Cambridge University, led by Professor Alastair Compston and Dr. Alasdair Coles, began investigating alemtuzumab as a treatment for MS in the 1990s, based on the hypothesis that depleting lymphocytes and allowing immune reconstitution could reset the dysregulated immune system driving MS.

Genzyme licensed alemtuzumab from Cambridge University and conducted clinical trials specifically for MS under the Lemtrada brand name. The pivotal Phase 3 CARE-MS I trial compared alemtuzumab to interferon beta-1a (Rebif) in treatment-naive patients with relapsing-remitting MS. CARE-MS I demonstrated that alemtuzumab significantly reduced the annualized relapse rate compared to interferon beta-1a, though it did not demonstrate a statistically significant difference in disability progression in this treatment-naive population.

The CARE-MS II trial compared alemtuzumab to interferon beta-1a in patients with RRMS who had relapsed on prior therapy. CARE-MS II demonstrated that alemtuzumab significantly reduced both the annualized relapse rate and the risk of sustained disability accumulation compared to interferon beta-1a in this population of inadequate responders to prior therapy. Both CARE-MS trials were published in The Lancet in 2012.

The European Medicines Agency approved Lemtrada in September 2013 for active relapsing-remitting MS. The FDA approved Lemtrada on November 14, 2014, for the treatment of patients with relapsing forms of MS. The FDA's approval was more restrictive than the EMA's, specifying that Lemtrada should generally be reserved for patients who have had an inadequate response to two or more disease-modifying therapies, reflecting the FDA's assessment of the drug's serious risk profile.

Lemtrada's approval was accompanied by a Risk Evaluation and Mitigation Strategy (REMS) program, which restricts access to the drug to certified prescribers, healthcare facilities, and pharmacies. The REMS program was implemented to manage the serious risks associated with Lemtrada, including autoimmune conditions (thyroid disorders, immune thrombocytopenic purpura, and nephropathies), serious infusion reactions, and an increased risk of malignancies.

In 2019, the EMA strengthened the restrictions on Lemtrada's use in Europe, limiting it to patients with highly active RRMS who have not responded adequately to at least two disease-modifying therapies, or patients with rapidly evolving severe RRMS. The EMA also implemented additional monitoring requirements and contraindications. These restrictions reflected post-marketing reports of serious cardiovascular events, including stroke and arterial dissection, occurring shortly after Lemtrada infusion.

Lemtrada's unique dosing schedule, which consists of two annual treatment courses (12 mg/day intravenously for 5 consecutive days in Year 1, followed by 12 mg/day for 3 consecutive days approximately one year later), provides durable disease control through immune reconstitution. After the lymphocyte depletion caused by alemtuzumab, the immune system reconstitutes over months to years, and the reconstituted immune system may be less prone to the dysregulated activity that drives MS. This mechanism allows many patients to achieve durable remission with just two treatment courses.