Alemtuzumab Approved in Mexico for Multiple Sclerosis

Alemtuzumab Approved in Mexico for Multiple Sclerosis

alemtuzumabExciting news was revealed from Genzyme at the beginning of February 2014, with the announcement that their formidable multiple sclerosis drug, Alemtuzumab, had been approved for use in Mexico. Known as the brand name Lemtrada, Alemtuzumab is specifically effectual for patients with relapsing remitting multiple sclerosis, also coined RRMS. This extremely common and debilitating form of multiple sclerosis causes increased physical deterioration and frequent episodes of clinical exacerbations of this virulent disease. The use of Alemtuzumab has proven in studies to slow down symptoms of physical demise, and in some cases reverse these signs of muscle and nerve deterioration.  Additionally, the administration of Alemtuzumab significantly reduces the frequent nature of negative physical clinical episodes.

The studies of Lemtrada {Alemtuzumab} have been comprehensive and vast, and have included roughly 1,500 patients. The approval of Alemtuzumab in Mexico was based on two Phase III studies which were randomized. Clinical participants received either Alemtuzumab or subcutaneous interferon (high-dose) beta-1a. All of the patients had active cases of relapsing remitting multiple sclerosis, with some participants being new to CARE-MS I treatment. Other patients in these studies had experienced refractory RRMS while on prior CARE-MS II therapy. In the CARE-MS I group the patients who were administered Lemtrada {Alemtuzumab} had an increased ability to access and maintain relapse free rates as compared to the group of participants who were dosed with the interferon beta-1a.  Additionally, the rate of disability accumulation was noticeably slowed for the patients who were dosed with Alemtuzumab in comparison to the patients who were given interferon beta-1a.  Patients in the aforementioned Phase III studies were commonly dispensed 12 milligrams of Alemtuzumab once per year for two annual years. The first dosage was given via intravenous infusion for five consecutive days, and the second course of Alemtuzumab was given on three consecutive days, approximately 12 months from the first dose, also via I.V.

Alemtuzumab {Lemtrada} has yet to receive approval in the United States, although it has gained approval in the EU, Canada and Australia. Mexico has also granted an orphan drug status to Lemtrada. Adverse effects from Alemtuzumab may include leukopenia, infections and lymphopenia, although it is generally well tolerated among the majority of patients. The opportunity for a novel and effective treatment for patients with RRMS is needed, particularly in Mexico where there are currently 15,000 people diagnosed with this life changing disease. Over 2.3 people worldwide are suffering from multiple sclerosis, and this number is only expected to rise.

LGM Pharma provides Alemtuzumab, CAS# 216503-57-0,  API for research and development purposes. Clients can be assured of quality API products and continuous support throughout the R&D process.

Products currently covered by valid US Patents are offered for R&D use in accordance with 35 USC 271(e) +A13(1). Any patent infringement and resulting liability is solely at buyer risk.

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LGM Pharma Acquires CDMO

On July 27, 2020, LGM Pharma announced its acquisition of the formulation development and drug product contract manufacturing business of Nexgen Pharma, Inc. As a result, you will notice our new logo and visuals throughout the website. We’re working on updates to reflect the exciting, expanded CDMO capabilities and services we now can offer you.

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