Last Updated on October 17, 2024 by The Health Master
Lupin Ltd has received marketing approval from the Subject Expert Committee (SEC) at Central Drugs Standard Control Organisation (CDSCO) for Ranibizumab.
Ranibizumab (trade name Lucentis among others) is a monoclonal antibody fragment (Fab) created from the same parent mouse antibody as bevacizumab. It is an anti-angiogenic that has been approved to treat the “wet” type of age-related macular degeneration (AMD, also ARMD), diabetic retinopathy, and macular edema due to branch retinal vein occlusion or central retinal vein occlusion.
The firm presented the proposal for marketing authorization based on the results of phase III multicentre clinical trial conducted in the country.
After detailed deliberation, the committee recommended for grant of approval for marketing, subject to the following condition such as the specifications of the drug should be equivalent to the reference product.
The firm shall submit phase IV clinical trial protocol within three months of the grant of marketing authorization.
Ranibizumab was developed by Genentech and marketed by them in the United States, and elsewhere by Novartis, under the brand name Lucentis. It is often used for age-related wet macular degeneration. Its effectiveness is similar to that of bevacizumab and aflibercept.
A 2017 systematic review update found that while ranibizumab and bevacizumab provide similar functional outcomes in diabetic macular edema, there is low-certainty evidence suggesting that ranibizumab is more effective in reducing central retinal thickness than bevacizumab.
Lupin is an innovation-led transnational pharmaceutical company headquartered in Mumbai, India. The Company develops and commercializes a wide range of branded and generic formulations, biotechnology products and APIs in over 100 markets in the US, India, South Africa and across Asia Pacific (APAC), Latin America (LATAM), Europe and Middle-East regions.
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