Mumbai: Biogen Idec Biotech India on Friday announced the approval of Tecfidera (dimethyl fumarate), an oral therapy for multiple sclerosis, by the Drug Controller General of India (DCGI) for people with relapsing-remitting multiple sclerosis (RRMS).
Multiple sclerosis (MS) is an immune-mediated life-long, progressive disease which affects brain and spinal cord, and is the most common cause of non-traumatic neurological disability afflicting young adults. Relapsing-remitting multiple sclerosis (RRMS) is the most common form of MS.
The approval of Tecfidera is based on data from a robust clinical development programme of two global Phase 3 studies that enrolled more than 2,600 patients. Patients from India also were part of clinical research, according to a statement by Biogen Idec Biotech India.
“We believe Tecfidera provides a new option for patients in India, particularly as it provides the convenience of oral dosing. As leaders in the MS space in India, Biogen Idec is committed to bringing innovative treatment options for patients in the country,” said Pooja Vatsyayan, acting managing director, Biogen Idec India.
Dr J D Mukherji, director, neurology, Max Hospital, Saket, New Delhi, said, “With the availability of Tecfidera, our MS patients will have an increased range of options including an oral alternative. It was always a challenge for patients to initiate treatment with an injectable therapy for a chronic condition such as MS. Tecfidera should help many patients initiate therapy conveniently.”
Dr Mukul Varma, senior consultant neurologist, Indraprastha Apollo Hospital, New Delhi, said, “Tecfidera has shown good results in clinical trials and with convenience of oral dosing; we hope it will improve the MS treatment experience for Indian patients.”