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The Subject Expert Committee (SEC) which advises the Central Drugs Standard Control Organisation (CDSCO) regarding various approvals for drugs in the country, has recommended grant of permission to import and market Roche's ocrelizumab 300 mg concentrate for solution for infusion noting that the proposed indication is for a rare disease with no treatment available.
The Swiss healthcare major has presented the proposal to import and market the drug indicated for treatment of relapsing forms of multiple sclerosis (RMS) to include clinically isolated syndrome, relapsing-remitting disease and active secondary progressive disease in adults; and primary progressive multiple sclerosis (PPMS) in adults, with local clinical trial waiver.
It has also presented the results of various global clinical trials conducted in the proposed indications. The drug product is approved in 100 countries globally including USA, European Union, Canada, Switzerland and Australia.
The Committee, which looks into the matters related to neurology and psychiatry, in its latest meeting noted "that the proposed indication of primary progressive multiple sclerosis is a rare disease with no treatment available at present."
The committee also noted that two global clinical trials (Study WN42086 and WA404040) are planned by the company, in which India is one of the participating countries.
After detailed deliberation, it recommended for grant of permission to import and market the drug for the proposed indications subject to certain conditions.
The conditions are that the firm should also submit post marketing safety data generated globally including Asian and Indian Population to CDSCO for review, it should conduct phase IV clinical trial and it should submit results of Global Clinical Trial proposed to be conducted in India once completed.
Accordingly, the firm should submit phase IV clinical trial protocol to CDSCO within three months of import and marketing approval, said the Committee.
Roche has its brand Ocrevus (ocrelizumab) for treating multiple sclerosis by targeting a type of immune cell called the CD20-positive B cell that plays a key role in the disease, says the company.
The company also states that the Ocrevus has twice-yearly (six-monthly) dosing and is the first and only therapy approved for RMS; (including RRMS and active, or relapsing, secondary progressive MS [SPMS], in addition to clinically isolated syndrome [CIS] in the US) and PPMS. The drug is approved in over 98 countries across North America, South America, the Middle East, Europe, as well as in Australia, says the company website.
Ocrevus was designated as a Breakthrough Therapy by the US Food and Drug Administration (FDA), and approved by the FDA in March, 2017 and by the European Commission in January, 2018, it added.
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