FDA Approves Efficacious and Long-Acting MS Drug Alemtuzumab


FDA Approves Efficacious and Long-Acting MS Drug AlemtuzumabAlemtuzumab, also known as the brand name MS drug Lemtrada, has recently gained a long awaited FDA approval. Genzyme spent over a decade developing this long-acting agent designed to effectively treat patients with relapsing Multiple Sclerosis. The unique method of dispensing Alemtuzumab is a significant plus for patients who do not tolerate current medication regimens which involve monthly, weekly and even daily injections. Administration of Alemtuzumab is given via two infusion treatment courses, one for five days in a row and another course approximately twelve months later for three days straight. With sixty percent of the global market for MS in the United States the advent of this novel and innovative treatment option for patients is encouraging.

Two successful randomized Phase III trials led to the FDA nod of approval on November 14, 2014. These open-label studies compared Lemtrada to Rebif, which is a subcutaneous interferon beta-1a treatment, considered as high dose. The patients enrolled in these pivotal studies were all diagnosed with refractory MS, having had previously unsuccessful treatments, or patients who were new to any type of biologic treatments. The patient population with no prior medication regimen was deemed the CARE-MS I group and the study participants who had relapsed despite past medical interventions was coined CARE-MS II.

In the CARE-MS I study group the use of Alemtuzumab proved to work with much greater efficacy as compared to the clinical trial participants who were dosed with interferon beta-1a (Rebif). Positive findings in the group of patients who received Alemtuzumab included a notable reduction in yearly relapse rates and a statistically insignificant number of disability relapse rates.  Alemtuzumab was efficacious for the patients in the CARE-MS II study group as well, with participants experiencing a sizable reduction in relapse rates annually, as well as a slowed accumulation in disability overall. A total of 1,500 patients were involved in both studies, with over 6,400 years of patient assessment and follow-up. Alemtuzumab, or Lemtrada will be marketed with a warning for patients that include risks such as potential life-threatening infusion reactions, autoimmune conditions and a higher risk of cancers like thyroid cancer and melanoma. Initial access to this potent therapy will be reserved strictly for patients with relapsed and refractory MS. Sanofi representatives have indicated the current pricing for Lemtrada will be approximately $158,000 for a two treatment regimen.

Astounding figures have been revealed regarding the noted efficacy of Alemtuzumab, with roughly 70 percent of patients displaying no need for further treatments after the initial two for over three years’ time. Study analysts believe that the ability of Alemtuzumab to elicit relapse free results of up to five years’ time is clearly possible, if not probable. Side effects of Alemtuzumab include headache, nausea, rash, diarrhea, back pain, dizziness and insomnia. Serious adverse effects are rare, and may include thyroid disease and pneumonitis. Lemtrada was approved by the EU in September of 2013 and is currently approved in over forty countries worldwide. LGM Pharma can assist clients as a supplier/distributor of Alemtuzumab, CAS # 216503-57-0, for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

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