Clinigen Group, the global pharmaceutical and services company, announces that its Specialty Pharma (SP) division 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 is a significant step forward in the assessment of the regulatory application, which should ultimately allow physicians to consider use in paediatric patients where high dose anthracycline therapy is planned.

Since Clinigen acquired Cardioxane in March 2013, the group has actively engaged with paediatric oncologists and cardiologists in the European Union (EU) and United States (US) to understand new data that 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 (2011).

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.

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 favorable safety profile for Cardioxane, which will also be reflected in the updated product information.

This represents a major regulatory achievement for the group and is a key milestone in the revitalisation of the Cardioxane brand by Clinigen SP.  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.

Ivo Timmermans, Chief Medical Officer of Clinigen said: “Paediatric oncologists and cardiologists have been limited in their options to effectively manage cardiotoxicity associated with anthracycline chemotherapy when used to treat certain childhood cancers. I am proud of the fact we have been able to work with EU and US experts and the regulatory agencies to reach this positive CHMP opinion, which should result in changes to the Cardioxane product information.”

Shaun Chilton, Group Chief Executive Officer of Clinigen said: “The CHMP positive opinion on Cardioxane follows a significant international effort between Clinigen, paediatric oncologists and cardiologists. This clearly demonstrates our capabilities in revitalising our products so that they can benefit more patients. It is a significant milestone in our history to be part of a change that could offer Cardioxane as an additional option for children being treated for certain types of cancer.”