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regular-article-logo Friday, 21 June 2024

‘Breakthrough’ medicine for multiple sclerosis, Roche Pharma launches ocrelizumab in India

Ocrelizumab is currently the only approved treatment for primary progressive multiple sclerosis and relapsing multiple sclerosis with a twice-yearly dosing regimen that patients are likely to prefer over alternatives that typically involve monthly injections or daily doses, Roche officials said

G.S. Mudur New Delhi Published 28.02.24, 06:41 AM
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Representational image File picture

Roche Pharma on Tuesday announced its launch in India of ocrelizumab, a medicine used to treat aggressive forms of multiple sclerosis, a chronic inflammatory neurological disorder, six years after the product was approved in the US.

Ocrelizumab is currently the only approved treatment for primary progressive multiple sclerosis and relapsing multiple sclerosis with a twice-yearly dosing regimen that patients are likely to prefer over alternatives that typically involve monthly injections or daily doses, Roche officials said.

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Multiple sclerosis is an auto-immune disorder in which immune system cells attack the body itself. The disorder may be mild in some patients but aggressive in others. Symptoms range from the loss of the ability to see clearly, write, speak or walk.

Neurologists have applauded the arrival of ocrelizumab which they say will provide patients an alternative to other currently available therapies, all of which are intended to not cure but modify the disease. But some doctors caution that cost could pose a challenge to sections of patients. The cost could range between Rs 9 lakh to Rs 12 lakh, depending on the patient’s weight and dosing requirements.

More than 3,00,000 patients have received ocrelizumab over the past decade and global data has suggested that around 80 per cent of patients who received the drug had adhered to the twice-yearly dosing after the second year of their treatment, Roche said.

The US Food and Drug Administration had designated ocrelizumab as a “breakthrough” therapy and approved the treatment in March 2017. Since then, the drug has been approved in over 100 countries, the company said in a media release.

An expert panel set up by the Central Drugs Standard Control Organisation, India’s drug regulatory authority, had last month approved Roche’s application to launch ocrelizumab in India on condition that it would conduct a post-launch study with a follow-up on patients for two years.

Neurologists who are treating patients with multiple sclerosis estimate that India has roughly 1,20,000 to 1,50,000 patients with multiple sclerosis. “These are estimates, we don’t have reliable epidemiological data,” said J.D. Mukherji, the head of neurology at the Max Superspeciality Hospital, New Delhi.

But, Mukherji said, it is also estimated that only about 15 per cent of diagnosed patients currently receive the ideal appropriate therapy. “There are several reasons for this — poor awareness, lack of access to treatment, and the cost of some medications,” Mukherji said. Ocrelizumab’s cost, he said, may also be a challenge to some patients.

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