Biogen finds long-term use of Tecfidera is safe and effective in MS

12th September 2019 (Last Updated December 23rd, 2019 09:28)

Biogen has reported that its multiple sclerosis (MS) drug Tecfidera maintained safety and effectiveness over a decade in participants of the ongoing Phase III ENDORSE extension study.

Biogen has reported that its multiple sclerosis (MS) drug Tecfidera maintained safety and effectiveness over a decade in participants of the ongoing Phase III ENDORSE extension study.

An analysis of 192 relapsing MS patients who were followed for a minimum of ten years revealed a ‘low incidence’ of relapses and disability progression.

According to the findings, around 51% of participants did not relapse with Tecfidera treatment over the study duration. Furthermore, 64% did not experience confirmed disability progression, while 79% retained the capacity to walk with no significant disability.

The safety profile of the drug was observed to be consistent over the ten-year period, without increased risk in adverse events.

A separate meta-analysis of data from 18 real-world studies found Tecfidera to be significantly more effective in decreasing annualised relapse rate and delaying time to first relapse compared to interferon beta, glatiramer acetate and teriflunomide.

Though the drug showed effectiveness comparable to that of fingolimod, it was found to be less effective than natalizumab and alemtuzumab.

Biogen executive vice-president and chief medical officer Alfred Sandrock said: “Biogen’s new data underscore Tecfidera’s role as a meaningful long-term therapy option for relapsing MS, with many patients in the study experiencing no relapses or progression in their disability over a ten-year period.”

The long-term results have been presented at the 35th Congress of the European Committee for Treatment and Research in MS (ECTRIMS) conference held in Stockholm, Sweden.

Biogen also reported positive data for the investigational diroximel fumarate therapy in the Phase III EVOLVE-MS-1 trial involving around 1,000 relapsing-remitting MS patients.

Interim results from 888 patients who received the investigational therapy for around 18 months showed diroximel fumarate to be generally well-tolerated.

The therapy led to a 79.4% reduction in annualised relapse rate and a 64.3% decrease in the number of gadolinium-enhancing lesions from baseline to 24 months.