Biogen Idec gets DCGI nod for multiple sclerosis oral drug

Biogen Idec Biotech India has received approval from the national drug controller for oral therapy drug for multiple sclerosis.
The company has received approval for the first oral therapy drug Tecfidera for multiple sclerosis by the Drug Controller General of India (DCGI), Biogen Idec Biotech India Pvt Ltd said in a statement.
The new medication will be available in the Indian market from second week of February 2015, it added.
Commenting on the development, Biogen Idec India Acting Managing Director Pooja Vatsyayan said: "We believe Tecfidera provides a new option for patients in India, particularly as it provides the convenience of oral dosing."

The approval of drug is based on data from a robust clinical development program of two global phase III studies that enrolled more than 2,600 patients. Patients from India also were part of clinical research, Biogen Idec India said.
Tecfidera is the first oral drug for the treatment of relapsing-remitting multiple sclerosis (RRMS) in India,it added.
Multiple sclerosis is a disease which affects brain and spinal cord and is the most common cause of non-traumatic neurological disability afflicting young adults, Biogen Idec India said.