Finally: FDA reverses course, OKs Sanofi's Lemtrada for MS
- After being rejected by the FDA last December based on safety concerns, Sanofi's Lemtrada (alemtuzumab) has finally been approved—but with qualifications. It is indicated for treatment of MS in patients who have been unresponsive to at least two other drugs.
- Lemtrada is given in two courses via an IV drip for five days and for three days one year later. The approval is based on Phase III trials comparing Lemtrada with Merck KGaA’s Rebif (interferon beta-1a). Lemtrada was significantly superior with respect to reducing annualized relapse rates.
- But industry watchers are only expecting $400 million in sales by 2018.
Analysts see some challenges with Lemtrada. Despite the fact that the drug has now passed the final regulatory hurdle, there is still the challenge of getting physicians on board with the therapy.
Lemtrada will most likely be reserved for hard-to-treat patients. Plus there's the labeling, which includes warning of a risk of autoimmune conditions, serious and life-threatening infusion reactions, and malignancies including thyroid cancer, melanoma, and lymphoproliferative disorders.
Critics also point out that, as an IV-mediated drug, Lemtrada is more difficult to use than the new class of oral treatments for MS, including Novartis' Gilenya (fingolomid) and Biogen Idec's Tecfidera (dimethyl fumarate). Regardless, having more than one treatment option is an important part of a thriving therapeutic category—and increasingly, MS is becoming a disease with multiple treatment options, now including a drug to "reprogram the immune system," a.k.a. Lemtrada.