Miljöpåverkan
Brolucizumab
Miljörisk:
Användning av aminosyror, proteiner och peptider bedöms inte medföra någon miljöpåverkan.
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Detaljerad miljöinformation
According to the European Medicines Agency (EMA) guideline for Environmental Risk Assessment of pharmaceuticals (EMEA/CHMP/SWP/4447/00 corr 2), an ERA consisting of a justification for not submitting ERA studies is sufficient for certain active pharmaceutical ingredients:
"In the case of products containing vitamins, electrolytes, amino acids, peptides, proteins, carbohydrates and lipids as active pharmaceutical ingredient(s), an ERA should be provided. This ERA may consist of a justification for not submitting ERA studies, e.g. due to their nature they are unlikely to result in a significant risk to the environment. The same applies to vaccines and herbal medicinal products."
Brolucizumab is a humanized single-chain Fv (scFv) antibody fragment with a molecular weight of ~26 kDa which inhibits vascular endothelial growth factor A (VEGF-A) binding to its receptors VEGFR1 and VEGFR2. It is indicated for the treatment of neovascular age-related macular degeneration (nAMD). Inhibition of the VEGF pathway has been shown to inhibit the growth of neovascular lesions and resolve retinal edema in patients with nAMD.
Brolucizumab is provided as 60 and 120 mg/mL solution for injection and is administered by intravitreal injection. In addition to the active pharmaceutical ingredient, the drug product contains the following excipients, which are either naturally occurring or not of environmental concern: sodium citrate, citric acid, polysorbate 80, sucrose and water for injection. The marketing of brolucizumab will not increase the use of any of those commonly used excipients to any significant extent.
Any active pharmaceutical ingredient that reaches water streams after use in patients, via eventual spills during brolucizumab application or after disposal of unused drug is expected to be very rapidly degraded by microbial activity.
Therefore, to the best of its knowledge, Novartis believes there is no appreciable risk for the environment emerging from the introduction of brolucizumab for the treatment of neovascular age-related macular degeneration. It is therefore deemed unnecessary to perform a detailed environmental risk assessment.
References
EMEA/CHMP/SWP/4447/00 corr 2. Guideline on the environmental risk assessment of medicinal products for human use. London, 01 June 2006.