Nanomedicines on the EU market
Nanomedicines have been on the market for more than 20 years. European authorities evaluate each drug before approving it and publishes information on their uses and characteristics.
The first nanomedicine was authorised by the European Commission in 1996. For every drug it evaluates, the European Medicines Agency (EMA) publishes a European public assessment report (EPAR) on its website explaining the use and characteristics of the drug.
Below are some examples of nanomedicines that are already on the market.
|Medicine||Active substance and platform/technology||Use||Advantages of nanoformulation|
|Abraxane||Solvent-free colloidal suspension of albumin-bound paclitaxel (active substance) in spherical nanoparticle form||Treatment of breast cancer, adenocarcinoma of the pancreas, non-small cell lung cancer||Solubility problems of active principle solved (paclitaxel itself insoluble in water). Less frequent and severe toxicity (nausea, vomiting, fatigue, arthralgia, myalgia, alopecia) in comparison to previous formulations|
|Caelyx||Pegylated liposomal doxorubicin||Treatment of metastatic breast cancer, cancer of the ovary, Kaposi’s sarcoma (a cancer of the blood vessels), multiple myeloma||Higher accumulation in tumour cells and increased circulation time – reduction of cardiotoxicity of doxorubicin|
|CosmoFer/INFeD/Ferrisat*||Dextran-coated iron nanoparticles for parenteral administration (injection)||Treatment of anaemia||More stable iron-carbohydrate complex compared to non-nano formulations – reduced toxicity (reduced nephrotoxicity, intracellular iron accumulation).|
|Rapamune||Sirolimus particles in a nanocrystal colloidal nanodispersion stabilised to reduce particle size||Prophylaxis of organ rejection in renal transplant patients||Improved stability and bioavailability|
*EPAR not available as authorisation was not granted through the European procedure.
- European Medicines Agency (EMA)
- European Medicines Agency: Reflection paper on general issues for consideration regarding coated nanomedicines
- European Commission: Medicinal products
- European Commission: Nanomedicine – the promise
- European Commission: Targeted Nano-pharmaceuticals and Early Diagnostics cluster
- International Pharmaceutical Regulators Forum (IPRF)
- Nanomedicine European Technology Platform
- ENATRANS – Enabling nanomedicine translation