Astellas files new drug for life-threatening infections
A new treatment for life-threatening infections most commonly affecting immunocompromised cancer patients has been filed with the FDA.
The drug, isavuconazole, is being co-developed by Astellas and Basilea, and has been filed for invasive aspergillosis and invasive mucormycosis (also known as zygomycosis).
Invasive fungal infections are among the leading causes of morbidity and death for patients with leukaemia and lymphoma who receive high-dose chemotherapy, sometimes followed by stem cell transplantation, all of which compromises the immune system.
In accordance with the FDA Prescription Drug User Fee Act (PDUFA), the FDA has designated 8 March, 2015 as the date for completion of the review.
The FDA has designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for both of the fungal infections.
QIDP is a special provision aimed at encouraging the development of new anti-infective drugs. The status means the drug will receive priority review and a five-year extension of market exclusivity in the United States. QIDP incentives were granted under the 2012 US Generating Antibiotic Incentives Now (GAIN) Act as a part of the FDA Safety and Innovation Act.
Isavuconazole was also granted Orphan Drug status for invasive aspergillosis and invasive mucormycosis which, if approved, will result in the product having seven years of market exclusivity in addition to that provided under the GAIN Act.
The filing coincides with new data on the drug which shows it is as effective as an existing drug, Pfizer's Vfend (voriconazole), against invasive mould disease in cancer patients with fewer adverse effects. The phase 3 non-inferiority trial was presented at the 54th Interscience Conference on Antimicrobial Agents and Chemotherapy, an infectious disease meeting of the American Society for Microbiology.
"There is a growing need for new antifungal therapies like isavuconazole because serious fungal infections caused by Aspergillus and other moulds are on the rise due to the increasing numbers of immunosuppressed patients, including those with active cancer," says Andrew Ullman of Julius Maximilians University in Wuerzburg, Germany, one of the researchers presenting data.
Ullman concluded "These infections are associated with high morbidity and mortality. If approved, isavuconazole has the potential to be an important new option for the treatment of these life-threatening fungal infections."
Analysts predict the drug could earn around $700 million in peak sales. Anti-infectives are a key therapy area for Astellas, which has another phase 3 drug, fidaxomicin, a new treatment for C difficile infection in paediatric patients.
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