New Delhi: For numerous patients struggling with multiple sclerosis (MS), there is a ray of hope in the form of a breakthrough drug now available in India — seven years after it was first launched in the US.
Swiss drugmaker Roche Pharma Tuesday announced the launch of Ocrelizumab, sold under the brand name Ocrevus, claiming that it can effectively help manage MS — a debilitating neurological condition — and impede disability progression.
In MS, the immune system attacks the protective sheath of myelin that covers nerve fibres and causes communication gaps between the brain and the rest of the body. Eventually, the disease can cause permanent damage or deterioration of the nerve fibres.
However, the signs and symptoms of MS vary widely between patients and depend on the location and severity of nerve fibre damage in the central nervous system. Some people with severe MS may lose the ability to walk independently, see, or talk, drastically affecting their quality of life.
MS is regarded as an incurable disease, even though its symptoms can be managed to some extent. Indian Council of Medical Research (ICMR) — India’s apex biomedical research body — estimates that the condition affects about 20 people per lakh population.
Roche said that Ocrevus was the first and only approved disease-modifying therapy for the two types of MS — Relapsing-remitting Multiple Sclerosis (RRMS) and Primary-progressive Multiple Sclerosis (PPMS).
RRMS, which is seen in over 80 percent of MS patients, is characterised by episodes of new or worsening signs or symptoms or relapses followed by periods of recovery or remission. On the other hand, PPMS is characterised by steadily worsening neurologic function without distinct attacks or remission periods.
According to Roche, Ocrevus is also the first and only approved high efficacy therapy with more than 3,00,000 patients treated globally, and there is now long-term safety and efficacy data available for the drug from experience gathered over 10 years.
Simpson Emmanuel, chief executive officer (CEO) and managing director of Roche Pharma India, said in a statement issued Tuesday that the introduction of Ocrevus represents a pivotal moment in the management of MS in India.
“Boasting formidable efficacy, streamlined administration, and a commendable long-term safety record, Ocrevus instills fresh optimism in individuals grappling with this formidable neurological condition,” he said.
Emmanuel added that the launch of Ocrevus in India underscores “our commitment to providing innovative solutions to address the burden of neurological disorders that is already one of the biggest health challenges globally and is only set to grow significantly”.
The drug, approved by the US Food and Drug Administration (FDA) in 2017 and now available in over 100 countries, needs to be administered as an intravenous injection twice every year.
Doctors have welcomed the move, although some worry that at its current price point of Rs 10-12 lakh/year, the drug could be out of reach for a vast majority of the country’s population.
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How the drug works
Ocrevus belongs to a class of drugs called humanised anti-CD20 monoclonal antibodies — indicating it contains engineered antibodies from cells derived from humans. It targets CD 20 markers on B lymphocytes, a type of white blood cells that fight infections, and is an immunosuppressive medication.
The drug works by suppressing the B lymphocytes from creating antibodies that attack the myelin sheath of the nerve fibers.
Roche said that real-world data has shown that in over 80 percent of people with RRMS and over 33 percent of people with PPMS treated with Ocrevus, there were no signs of disability progression. Starting Ocrevus two years earlier saved almost 10 years of disease progression in people with RRMS, the firm added.
It also said that 92 percent of people with RRMS who received Ocrevus earlier did not need a walking aid, while 80 percent of people with PPMS did not require a wheelchair after 10 years of initiating and continuous therapy with Ocrevus.
Dr M.V. Padma Srivastava, chairperson of the department of neurology at Gurugram’s Paras Health Hospital, said that for those with relapsing MS who experience disease activity and worsening disability despite available treatments, Ocrelizumab emerges as a breakthrough solution.
“I also strongly recommend early initiation of such treatment for better outcome,” she said.
However, Dr. J.D. Mukerjee, head of neurology at Delhi’s Max Hospital, advised caution in its use, saying that though very effective, in a very small subset of patients, the drug can also trigger strong adverse events such as anaphylaxis — a severe, potentially life-threatening reaction that involves the whole body.
A small number of patients have also reported the risk of increased infections, he said, adding that the drug could be unaffordable for the majority of the patients in India.
But Sandeep Chitnis, national honorary of the MS Society of India — a not-for-profit for patients of the disease — said that efforts were underway to get the disease classified as rare, have insurance companies cover treatment costs, and get it exempted from the Goods and Services Tax (GST) and import duties.
“For rare diseases, the government offers financial support to patients through select institutions. We are trying to ensure that MS is also categorised as a rare disease,” he said.
(Edited by Uttara Ramaswamy)
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