Schering-Plough’s new anti-fungal gains EMEA approval
pharmafile | July 29, 2005 | News story | Sales and Marketing |Â Â Â
A new treatment for fungal infections has been given a positive opinion by the EMEA.
Schering-Plough's Noxafil (posaconazole) is a novel triazole anti-fungal and will be used to treat some of the most serious invasive fungal infections in patients who have failed to respond to, or are intolerant of other treatments.
The recommendation is expected to lead to full marketing approval across the EU's 25 member states as well as Iceland and Norway within the next few months.
Invasive fungal infections can be life-threatening and most often occur in people whose immune system has been compromised or suppressed, such as organ transplant patients or cancer patients undergoing chemotherapy or stem cell transplant.
"I am pleased the CHMP has granted a positive opinion for posaconazole in refractory invasive fungal infections. This will offer the medical community in Europe an oral therapy for severely ill patients who are struggling not only with their haematological malignancies but also with difficult fungal infections requiring long-term treatment," said Raoul Herbrecht, professor and head of haematology in the Department of Haematology and Oncology, University Hospital of Strasbourg.
The positive opinion is based on clinical trial data of Noxafil 400mg twice daily to treat invasive aspergillosis in patients with refractory disease or who were intolerant of other medicinal products.
A successful response (complete or partial resolution) was seen in 42% of patients treated with Noxafil compared to 26% of patients in an external control group.
Noxafil will compete with Merck Sharp & Dohme's Cancidas (caspofungin) and Pfizer's Vfend (voriconazole) two anti-fungals already on the market licensed to treat invasive aspergillosis. Vfend is in the same triazole as Noxafil whereas Cancidas is a peptide anti-fungal, but sales of both products are growing rapidly.
The study also showed that Noxafil was effective against invasive fungal infections caused by fusarium, agents of chromoblastomycosis and mycetoma, and coccidioides.
The launch contributes to Schering-Plough's strategy to broaden its anti-infectives portfolio. In the US, the company markets Avelox (moxifloxacin) and Cipro (ciprofloxacin) two of the most powerful anti-bacterial drugs on the market.
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