Roche gets CDCSO panel nod to market multiple sclerosis drug Ocrelizumab
New Delhi: Pharmaceutical major, Roche has got a go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Control Organisation (CDSCO) to import and market Ocrelizumab 300mg concentrate for solution for infusion, indicated for treatment of relapsing forms of multiple sclerosis (RMS) and primary progressive multiple sclerosis (PPMS).
However, this approval is subject to the condition that the firm should also submit post marketing safety data generated globally, including Asian and Indian populations, to CDSCO for review and conduct a Phase IV clinical trial.
This came after the drug major, Roche presented the proposal to import and market Ocrelizumab 300 mg concentrate for solution for infusion indicated for the treatment of relapsing forms of multiple sclerosis (RMS) including clinically isolated syndrome, relapsing-remitting disease, and active secondary progressive disease in adults, and primary progressive multiple sclerosis (PPMS) in adults with a local clinical trial waiver.
In addition to the above the drug major, Roche presented the results of various global clinical trials conducted in the proposed indications. Furthermore, it stated that the drug product is approved in 100 countries globally, including the USA, EU, Canada, Switzerland, and Australia.
Multiple sclerosis (MS) is a disease of the central nervous system, which is made up of the brain, spinal cord, and optic nerve. This disorder causes destruction of the coating (myelin) that surrounds and protects nerve fibres (axons). As a result, the damage disrupts the normal flow of messages (nerve impulses) from the central nervous system (CNS), causing a reduction or loss of body function. In many cases, the nerve fibres (axons) are also destroyed.
Primary-progressive multiple sclerosis (PPMS) is a form of the disease that is characterized from the beginning of the disease as a progressively worsening condition.Relapsing multiple sclerosis (MS) is a progressive disease that causes damage to the central nervous system (CNS).
Ocrelizumab is a CD20-directed cytolytic antibody indicated for the treatment of patients with primary progressive or relapsing forms of multiple sclerosis (MS). It is a second-generation recombinant humanized monoclonal IgG1 antibody that selectively targets B-cells that express the CD20 antigen.
Developed by Genentech/Roche, ocrelizumab was approved by the FDA in March 2017 under the market name Ocrevus for intravenous injection. It was later approved by Health Canada in August 2017, making the drug the first available treatment for PPMS in both the US and Canada.
At the recent SEC meeting for Neurology & Psychiatry held on the 17th of January 2022, the expert panel reviewed the proposal to import and market the Ocrelizumab 300mg concentrate for solution for infusion presented by drug major Roche.
The committee observed that two global clinical trials (Studies WN42086 and WA404040) are also planned in which India is one of the participating countries.
After detailed deliberation, the committee recommended the grant of permission to import and market the drug for the proposed indications with the condition that:
(1) The firm should also submit post-marketing safety data generated globally, including the Asian and Indian populations, to CDSCO for review.
(2) The firm should conduct a Phase IV clinical trial.
(3) The firm should submit the results of the Global Clinical Trial proposed to be conducted in India once completed.
In accordance with the above, the committee stated that the firm should submit the Phase IV clinical trial protocol to CDSCO within three months of import and marketing approval.
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