Schering-Plough receives new EU Noxafil approval

The European Commission has granted Schering-Plough new marketing approvals for Noxafil, an oral suspension drug that can now be used to prevent the occurrence of invasive fungal infections in high-risk patients.

Noxafil has also been approved for use in cases of oropharyngeal candidiasis, a mouth and throat infection.

Schering-Plough states that the invasive fungal infections most commonly occur in patients demonstrating some level of immunosuppression or a compromised immune system. Patients who catch such an infection have a high probability of death.

For example, subjects with acute myeloid leukaemia or myelodysplastic syndromes who are infected with a fungal antigen have a mortality rate ranging between 50 per cent an 90 per cent, the company states.

Oliver Cornely of the University of Cologne, who was the lead study investigator for trials submitted for the approval process, remarked: “The approval of Noxafil for prophylaxis of invasive fungal infections in high-risk patients has the potential to change medical practice in this area.”

Robert J Spiegel, Schering-Plough’s chief medical officer, added: “With this approval, Noxafil is now approved in the European Union for both prophylaxis and treatment indications, broadening its utility to physicians as an important antifungal agent.”

Last month, Schering-Plough announced a deal with OncoMethylome Sciences to develop new treatment for cancers.