Clinigen Group PLC (LON:CLIN) has received a significant boost with the European authorities giving the green light for the use of Cardioxane in children undergoing chemotherapy.
The AIM-listed group acquired the drug in 2013 and had been working hard in both Europe and the US since then to support a change in the labelling of the anti-toxicity treatment.
Clinigen said it has now received a positive opinion from European medicines assessor CHMP and it anticipates the European Commission will accept this opinion and 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.”
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Shaun Chilton, Clinigen’s chief executive added: "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."
Once final EC approval is obtained, physicians will be able to consider using Cardioxane to protect the hearts of paediatric cancer patients who receive a cumulative dose of more than 300mg/m2 of doxorubicin or another anthracycline.
One of the side effects of using anthracyclines in children is they can cause heart damage while treating the tumour, which can mean the patient dies of heart failure earlier than they would otherwise.
Cardioaxane helps to reduce this risk and it was a joint effort between Clinigen and heart and cancer specialists to get the positive opinion.
Ivo Timmermans, Clinigen’s chief medical officer 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.
The safety profile for Cardioxane’s use in adults will be also be more favourable in the updated product information, while getting European approval also opens up markets that tend to follow its guidelines, such as Latin America.
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