NORTHBROOK, Ill., Oct. 8, 2014 /PRNewswire/ -- Astellas reported today that isavuconazole demonstrated successful outcomes in the treatment of mucormycosis according to data from the phase 3 isavuconazole VITAL study being presented at IDWeek on October 10, 2014, in Philadelphia, Pa.

The data assessed the efficacy and safety of isavuconazole in the treatment of patients with invasive mucormycosis (n=37) enrolled in the open-label, multicenter VITAL trial. Overall response at end of treatment, based on clinical, mycological and radiological criteria was assessed by an independent data review committee. Successful overall response at the end of isavuconazole treatment was observed in 31.4 percent of patients. The overall mortality rate was 37.8 percent and 43.2 percent through Day 42 and 84, respectively. Further, more than half (54.5 percent) of patients refractory (n=11) to prior antifungal therapy were alive through Day 84.

No new safety issues related to isavuconazole were identified in the study population. Treatment-emergent adverse events (TEAEs) and study drug-related TEAEs were reported in 35 (94.6 percent) and 13 (35.1 percent) patients with invasive mucormycosis, respectively. The most common TEAE occurring in patients treated with isavuconazole was vomiting (32.4 percent); diarrhea, nausea and pyrexia were equally the next most common TEAEs (27.0 percent for each). Three (8.1%) patients were reported by the investigator to have study drug-related serious AEs.

Invasive mucormycosis (IM) is an aggressive fungal disease caused by Mucorales molds in immunocompromised patients.[i][ii] The prognosis for IM is poor: the mortality rate can reach 70 percent, and may be even higher in disseminated disease.[iii]

"The VITAL study results which demonstrate that isavuconazole is active against mucormycosis, are promising, as this is a highly fatal disease in which patients are often refractory to or intolerant of treatment," said Bernie Zeiher, M.D., executive vice president, Global Development and therapeutic area head of Infectious Disease at Astellas. "There is a real need for additional therapies for this devastating disease."

The U.S. Food and Drug Administration (FDA) has accepted for filing the New Drug Application (NDA) for isavuconazole for the treatment of invasive aspergillosis and invasive mucormycosis (also known as zygomycosis). In accordance with the FDA Prescription Drug User Fee Act (PDUFA), the FDA designated the date of March 8, 2015 for the completion of the review. 

The FDA designated isavuconazole as a Qualified Infectious Disease Product (QIDP) for both invasive aspergillosis and invasive mucormycosis. QIDP status provides priority review and a five-year extension of market exclusivity in the United States. QIDP incentives were granted under the 2012 U.S. Generating Antibiotic Incentives Now (GAIN) Act as a part of the FDA Safety and Innovation Act. Also, in 2013, isavuconazole was 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.

Isavuconazole posters and presentations at IDWeek 2014

• A phase 3, randomized, double-blind, non-inferiority trial to evaluate efficacy and safety of isavuconazole versus voriconazole in patients with invasive mold disease (SECURE): outcomes in invasive aspergillosis patients – D. Kontoyiannis, M. Giladi, M. Lee, M. Nucci, I. Raad, E. Bow, V.A. Morrison, J. Baddley, B. Zeiher, R. Maher, W. Huang, K. Marr; Oral; Friday, October 10, 2:15 PM, 109-AB
• A phase 3, randomized, double-blind, non-inferiority trial to evaluate efficacy and safety of isavuconazole versus voriconazole in patients with invasive mold disease (IMD): outcomes in patients with pulmonary infections – I. Raad, K.M. Mullane, D. Selleslag, G. Thompson, D. Neofytos, S. Shoham, M. Lee, R. Maher, B. Zeiher, F. M. Marty; Poster; Friday, October 10, 12:30-2:00 PM, Hall BC
• A phase 3, randomized, double-blind, non-inferiority trial to evaluate efficacy and safety of isavuconazole versus voriconazole in patients with invasive mold disease (SECURE): outcomes in neutropenic patients – T. Patterson, D. Selleslag, K. Mullane, O.A. Cornely, W. Hope, O. Lortholary, B. Zeiher, R. Maher, M. Lee, W. Huang, D. Kontoyiannis; Oral; Friday, October 10, 2:00 PM, 109-AB
• An open-label phase 3 study of isavuconazole (VITAL): focus on mucormycosis – F.M. Marty, J.R. Perfect, O.A. Cornely, K.M. Mullane, G. Rahav, M. Lee, M. Ito, R. Maher, B. Zeiher, L. Ostrosky-Zeichner; Poster; Friday, October 10, 12:30-2:00 PM, Hall BC
• Health economic outcome analysis of patients randomized in the SECURE phase 3 trial comparing isavuconazole to voriconazole for primary treatment of invasive fungal disease caused by aspergillus species or other filamentous fungi – N. Khandelwal, B. Franks, F. Shi, J. Spalding, N. Azie; Poster; Friday, October 10, Hall BC

About Isavuconazole (proposed trade name: Cresemba^®)

Isavuconazole (drug substance: isavuconazonium sulfate) is an investigational once-daily intravenous and oral broad-spectrum antifungal being developed for the treatment of severe invasive and life-threatening fungal infections. Isavuconazole is the active moiety of the prodrug isavuconazonium sulfate. Information regarding isavuconazole ongoing clinical trials is available at clinicaltrials.gov.  Isavuconazole demonstrated in-vitro and in-vivo coverage of a broad range of yeasts (such as Candida species) and molds (such as Aspergillus species) as well as activity against emerging and often fatal molds including those that cause mucormycosis.

In the phase 3 invasive aspergillosis study, isavuconazole demonstrated non-inferiority to voriconazole on the primary endpoint of all-cause mortality at day 42. The treatment-emergent adverse events for isavuconazole were statistically fewer relative to voriconazole in the System Organ Classes of hepatobiliary, skin and eye disorders. In both treatment groups, the most common treatment emergent adverse events were nausea, vomiting, pyrexia (fever) and diarrhea. Isavuconazole is being co-developed with Basilea Pharmaceutica International Ltd.

About Astellas Infectious Disease

Astellas' commitment to the field of infectious diseases is an active one. We're expanding the knowledge base of this therapeutic area and empowering physicians to make evidence-based clinical decisions.

Our proud history of collaborating with investigators around the world provides ideal environments to study compounds that have the potential for significant breakthroughs and allows us to generate and publish key information on our advances. In fact, Astellas has performed some of the world's largest clinical trials in fungal infections.

About Astellas

Astellas is a pharmaceutical company dedicated to improving the health of people around the world through provision of innovative and reliable pharmaceuticals. For more information on Astellas, please visit our website at www.astellas.us. Follow us on Twitter at www.twitter.com/AstellasUS.

About IDWeek 2014™

IDWeek 2014™ is an annual meeting of the Infectious Diseases Society of America (IDSA), the Society for Healthcare Epidemiology of America (SHEA), the HIV Medicine Association (HIVMA) and the Pediatric Infectious Diseases Society (PIDS). With the theme "Advancing Science, Improving Care," IDWeek features the latest science and bench-to-bedside approaches in prevention, diagnosis, treatment, and epidemiology of infectious diseases, including HIV, across the lifespan. IDWeek 2014 takes place October 8-12 at the Pennsylvania Convention Center in Philadelphia, Pennsylvania. The full name of the meeting is IDWeek 2014™. For more information, visit www.idweek.org.

[i] Lewis, RE & Kontoyiannis, DP. 2013. Future Microbiol. 8:1163–1175
[ii] Petrikkos, G, et al. 2012. Clin. Infect. Dis. 54(Suppl 1):S23–34
[iii] Roden, MM, et al. 2005. Clin. Infect. Dis. 41:634–653

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