DCGI approves Biogen’s MS drug

The national drug controller has approved Biogen’s multiple sclerosis (MS) oral drug

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The drug will be available from second week of February 2015

Biogen has received approval for the first oral therapy drug Tecfidera for multiple sclerosis by the Drug Controller General of India ( DCGI).

According to the company, The new medication will be available in the Indian market from second week of February 2015. Tecfidera is the first oral drug for the treatment of relapsing-remitting multiple sclerosis (RRMS) in India, it added.

"We believe Tecfidera provides a new option for patients in India, particularly as it provides the convenience of oral dosing," said Ms Pooja Vatsyayan, Biogen India's acting managing director,  in a statement.

The approval of drug is based on the data from a robust clinical development program of two global phase III studies that enrolled more than 2,600 patients.

 

 

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