Regulatory Affairs

Clinigen gets EC nod to update product information for Cardioxane

Published 09 August 2017

Clinigen Group has secured approval from the European Commission (EC) to update the current product information for Cardioxane.

Cardioxane is an oncology support drug that prevents chronic cumulative cardiotoxicity caused by high dose anthracycline chemotherapy. In 1992, it was licensed for international markets but its label was revised in Europe as a result of an Article 31 referral in 2011. This restricted its indication and introduced a paediatric contraindication.

The EC approval follows a positive opinion issued by the EMA Committee for Medicinal Products for Human Use (CHMP) in May 2017, which was highlighted in the Group's trading update on 18 July, 2017.

Approval will enable physicians to consider the use of Cardioxane in paediatric patients where high dose anthracycline therapy is planned. The product information will also be updated to reflect a more favourable safety profile for Cardioxane in adult populations at the same time.

Since Clinigen acquired Cardioxane three and a half years ago, a multi-disciplinary team at Clinigen has actively engaged with an extensive group of international paediatric oncologists and cardiologists. The aim was to achieve updates to the product information, especially concerning the paediatric population, to align with new data.

Clinigen will implement appropriate safety measures to ensure the continued safe use of the product and to expand the clinical understanding in the paediatric population and will submit amendments to the labelling in countries where Cardioxane licences are held.

Merav Edan, Head of Regulatory Specialty Pharmaceuticals of Clinigen said:

"EC approval is the final step to ensuring that the paediatric oncologists can effectively manage cardiotoxicity associated with anthracycline chemotherapy by using Cardioxane when needed. Not only that, the additional changes to the Cardioxane product information will extend its use in the adult population."

Shaun Chilton, Group Chief Executive Officer of Clinigen said: "Final approval to enable Clinigen to implement the label change is a milestone achievement. This decision has been the work of many years, driven by a dedicated Clinigen team with the growing support of healthcare professionals. The impact for Cardioxane usage will not be immediate but this is a major regulatory achievement for us and demonstrates our ability to revitalise products so that they can benefit more patients over the long term."

Source: Company Press Release