Orphan drug for Astellas
pharmafile | May 29, 2013 | News story | Sales and Marketing | Astellas, Isavuconazole, Orphan
The FDA has granted orphan designation to one of Astellas’ Phase III drugs designed to treat potentially life-threatening fungal infections in patients whose systems are already compromised.
The Japanese firm’s isavuconazole is intended for patients who have invasive aspergillosis, which occurs in up to 13% of those who receive bone marrow transplants.
This is significant because research suggests that mortality rates for transplant patients with the disease are between 34% and 58 per cent.
It is also estimated to be present in up to a quarter of patients who have had heart or lung transplants, and up to a fifth of those receiving intensive chemotherapy for leukaemia.
The advantage to Astellas of the US regulator giving isavuconazole this status is that there will be a seven-year period of market exclusivity for the drug in the US following approval.
“Invasive fungal infections are life-threatening diseases primarily afflicting immuno-compromised patients,” said Bernie Zeiher, immunology/infectious disease/transplant therapeutic area head of Astellas Pharma Global Development.
“Pre-clinical and early clinical data suggest that isavuconazole may provide an alternative treatment for patients suffering from these conditions,” he added.
Topline data from two isavuconazole Phase III studies are expected to be published in the second half of 2013.
The SECURE registration study is looking at the safety and efficacy of once-daily isavuconazole versus twice-daily voriconazole, for the primary treatment of invasive fungal disease caused by Aspergillus species.
The open-label VITAL study is examining Astellas’ drug in patients with invasive life-threatening fungal disease caused by emerging fungi, and the treatment of aspergillosis patients with pre-existing renal impairment.
Another Phase III study, ACTIVE, will continue to recruit into next year: it will look at the use of an intravenous version of isavuconazole – as well as an oral one – against caspofungin IV followed by oral voriconazole for the treatment of invasive Candida infections.
The FDA has had its eye on isavuconazole, granting it fast-track status in a bid to ease development and speed up its review since it would be treating serious diseases and may fulfill an unmet medical need.
Adam Hill
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