PR Newswire | 13 Feb, 2015
MUMBAI: Biogen Idec Biotech India Pvt. Ltd. (Biogen Idec India) today announced the approval of the first oral therapy for multiple sclerosis, TECFIDERA (dimethyl fumarate), by the Drug Controller General of India (DCGI) for people with relapsing-remitting multiple sclerosis (RRMS). The new medication will be available in the Indian market, commencing the second week of February 2015.
TECFIDERA is the first oral drug for the treatment of RRMS in India.
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 program of two global Phase 3 studies that enrolled more than 2,600 patients. Patients from India also were part of clinical research.
"We are delighted to bring TECFIDERA, the first oral treatment for MS patients to 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."
TECFIDERA is the third therapy that Biogen Idec India offers to people living with MS in the country.
About Biogen Idec Biotech India Pvt. Ltd.
Biogen Idec Biotech India Pvt. Ltd. is the Indian affiliate of Biogen Idec. Through cutting-edge science and medicine, Biogen Idec discovers, develops and delivers to patients worldwide innovative therapies for the treatment of neurodegenerative diseases, hemophilia and autoimmune disorders. Founded in 1978, Biogen Idec is the world's oldest independent biotechnology company. Patients worldwide benefit from its leading multiple sclerosis therapies. For press releases and additional information about the company, please visit www.biogenidec.com.
Additional resources on TECFIDERA are available to the media upon request.
Patients should speak to their doctor if they have any requests around TECFIDERA or MS.
Full prescribing details can be obtained from Biogen Idec India upon request.
Ms Sukhmani Bikram,