The drug is approved for the treatment of SMA in adults and children 2 months of age and older, Roche said adding that it was approved by the Indian health authorities after reviewing its efficacy and safety data from three global clinical studies designed to represent a broad spectrum of people living with SMA.
Pharma major Roche on Thursday said it has launched prescription medicine Evrysdi in India, which is used for treatment of spinal muscular atrophy (SMA) in adults, children aged 2 months and older, at a maximum retail price of around Rs 6 lakh per bottle. Evrysdi was first approved by the United States Food and Drug Administration (US FDA) in August 2020 and is now available in India within 11 months of the US approval. Since its launch, over 4,000 SMA patients across over 50 countries have benefitted from the drug, Roche said in a statement.
Evrysdi is administered daily at home orally and is designed to treat spinal muscular atrophy by increasing production of the survival motor neuron (SMN) protein, it added.
The drug is approved for the treatment of SMA in adults and children 2 months of age and older, Roche said adding that it was approved by the Indian health authorities after reviewing its efficacy and safety data from three global clinical studies designed to represent a broad spectrum of people living with SMA.
“Today heralds a new journey of hope as we are all coming together to add color into the lives of SMA patients in India with the launch of Evrysdi, the first and only approved treatment in India for patients living with SMA.
“This also marks our foray into rare disease treatment in India,” Roche Pharma India CEO and MD V Simpson Emmanuel said.
The company also announced its patient support programme for Evrysdi to drive access to the drug. It also said Roche will provide free home delivery of the drug to each and every patient following consent from the patient/ caregiver and their healthcare professionals.
As part of the patient support programme, in the first two years of treatment, Roche will provide three bottles free for every two bottles bought by the patient, the company said.
From the third year onwards, the company will provide two bottles free for every one bottle bought by the patient, it added.
“Administration of Evrysdi requires no hospitalisation, no anesthesia, no specialised care center, no complex administration, and no steroids,” Roche Pharma India Chief Medical Officer Bruno Jolain said.
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