The Specialty Pharma (SP) division of Clinigen, has achieved a positive CHMP opinion in Europe to modify the current product information for Cardioxane.
It is expected that the European Commission (EC) will accept the CHMP opinion and will issue its approval later this year.
This should ultimately allow physicians to consider use in paediatric patients where high dose anthracycline therapy is planned.
Once final EC approval is obtained, physicians will be able to consider using Cardioxane to protect the hearts of paediatric cancer patients when they plan to administer a cumulative dose of more than 300mg/m2 of doxorubicin or the equivalent cumulative dose of another anthracycline.
Background
Since Clinigen acquired Cardioxane, it has actively engaged with paediatric oncologists and cardiologists in the EU and US to understand new data which supported a change to the product information.
This work has been driven by a common desire for physicians in the EU to be allowed to use Cardioxane in children who previously did not have that option, due to the paediatric contraindication introduced during the Article 31 referral.
The safety profile of the product was also reassessed in the adult population. The regulatory authorities have agreed that the new data demonstrates a more favourable safety profile for Cardioxane, which will also be reflected in the updated product information.