SEC recommends permission for Roche’s ophthalmic drug faricimab with local phase III trial waiver
The expert committee which advises the drug regulator on clinical trials and drug approvals has recommended for grant of permission for import and marketing of Swiss multinational pharma major Roche’s ophthalmic drug faricimab intravitreal injection in India, with waiver of local phase III clinical trial subject to conditions.
The product, faricimab 6mg/0.05 ml solution for intravitreal injection, launched in US under the brand Vabysmo, has been proposed by Roche Products (I) Pvt Ltd for treatment of Neto vascular (wet) age-related macular degeneration (nAMD) and diabetic macular edina (DME) with a request for the waiver of phase III clinical trial in the country.
The Subject Expert Committee (SEC) for ophthalmology, considered the proposal and noted that the applied drug is approved in 57 countries including USA, Canada, European Union, Australia, Japan, United Kingdom and others and the product has a novel mechanism of action in comparison to existing products.
Further, the firm stated that in the phase III clinical trials performed globally there were Asian population also.
“After detailed deliberation, the committee recommended grant of permission for import and marketing of the drug with local phase III clinical trial waiver subject to condition that firm should conduct phase IV clinical trial,” said the SEC in its recent meeting. Accordingly, phase IV clinical trial protocol should be submitted within three months of marketing approval, it added.
The drug was approved by the US Food and Drug Administration (FDA) in early 2022 and has been pitted by experts against Regeneron’s blockbuster drug Eylea.
Neovascular AMD and DME are two leading causes of vision loss worldwide, said Roche during the announcement of its approval with the US FDA on January 31, 2022.
Vabysmo targets and inhibits two disease pathways linked to a number of vision-threatening retinal conditions by neutralising angiopoietin-2 (Ang-2) and vascular endothelial growth factor-A (VEGF-A). It is the first and only FDA-approved injectable eye medicine for nAMD and DME that improves and maintains vision with treatments from one to four months apart in the first year following four initial monthly doses, based on evaluation of the patient’s anatomy and vision outcomes. Standard of care for nAMD and DME typically requires eye injections every one to two months, said the company.
AMD is a condition that affects the part of the eye that provides sharp, central vision needed for activities like reading. Neovascular or “wet” AMD (nAMD) is an advanced form of the disease that can cause rapid and severe vision loss if left untreated.
The company added that DME, affecting around 21 million people globally, is a vision-threatening retinal condition associated with blindness and decreased quality of life when left untreated. DME occurs when damaged blood vessels in the retina leak into and cause swelling in the macula – the central area of the retina responsible for the sharp vision needed for reading and driving. The number of people with DME is expected to grow as the prevalence of diabetes increases, it says.
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