Last Updated on October 15, 2024 by The Health Master
New Delhi: Pharmaceutical major, Roche has gotten the go-ahead from the Subject Expert Committee (SEC) functional under the Central Drug Control Organization (CDSCO) to import and market Ocrelizumab 300 mg 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 in Asian and Indian populations, to CDSCO for review and conduct a Phase IV clinical trial.
What is Multiple sclerosis ?
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).
SEC meeting
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:
- The firm should also submit post-marketing safety data generated globally, including the Asian and Indian populations, to CDSCO for review.
- The firm should conduct a Phase IV clinical trial.
- 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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