Mumbai: Biogen Idec Biotech India Thursday said it has received approval for the first oral treatment TECFIDERA for multiple sclerosis in India.
"We have received 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)," a company statement said here.
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 programme of two global Phase 3 studies that enrolled more than 2,600 patients. Patients from India also were part of clinical research.
"We are bringing 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.
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."