India's first medicine to treat Duchenne muscular dystrophy cleared for testing

5 October 2020

After 13 years of research, India's first personalized medicine for Duchenne muscular dystrophy (DMD) has received the green signal from the Drug Controller General of India (DCGI), paving the way for clinical trials.

The DCGI has not provided details of the compound it has approved, but noted that what is approved in the USA has been indigenously made in India.

In the USA, there are two types of antisense therapies for DMD: eteplirsen (Exondys 51 from Sarepta Therapeutics [Nasdaq: SRPT]) and drisapersen, from BioMarin Pharmaceutical (Nasdaq: BMRN), with only eteplirsen approved for marketing.

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