Adult Populations 
Cresemba is as efficacious as the standard of care for both invasive aspergillosis and mucormycosis ^2,3

Explore the study results for CRESEMBA^® (isavuconazole) for the treatment of invasive aspergillosis with the SECURE study and mucormycosis in the VITAL study.

Invasive aspergillosis

SECURE - Double-blind, randomised-controlled, non-inferiority, multicentre international trial, a phase 3 trial comparing CRESEMBA^® and voriconazole for the primary treatment of invasive mould disease caused by Aspergillus species and other filamentous fungi.¹

^{a. Hepatic dysfunction: bilirubin ≥3 x ULN, alanine transaminase or aspartate transaminase ≥5 x ULN, cirrhosis or chronic hepatic failure; moderate-to-severe renal dysfunction: calculated creatinine clearance <50 mL/min. ITT, intention-to-treat; IV, intravenously; mITT, modified intention-to-treat; PO, per os (orally); ULN, upper limit of normal; q8h, every 8 hours; q12h, every 12 hours; q24h, every 24 hours.}

• In the SECURE trial (invasive aspergillosis), both survival rates and overall treatment response were comparable^b with CRESEMBA^®and voriconazole²
  • Survival rates (ITT): Treatment difference -1.1% (95% CI: -8.9, 6.7) p=0.744
  • Overall treatment response at end of treatment (mITT): 35% (n=50/143) vs 36% (n=47/129). Adjusted treatment difference 1.6% (95% CI: -9.3, 12.6)

b.Patients were censored on the day of their last known survival status

Mucormycosis

• In the VITAL trial – a single-arm, open-label trial and case control analysis – mucormycosis cases treated with CRESEMBA^® as primary treatment (n=37) were matched with controls from the FungiScope Registry who received primary amphotericin B-based treatment³

^{a. Hepatic dysfunction: bilirubin ≥3 x ULN, alanine transaminase or aspartate transaminase ≥5 x ULN, cirrhosis or chronic hepatic failure; moderate-to-severe renal dysfunction: calculated creatinine clearance <50 mL/min. ITT, intention-to-treat; IV, intravenously; mITT, modified intention-to-treat; PO, per os (orally); ULN, upper limit of normal; q8h, every 8 hours; q12h, every 12 hours; q24h, every 24 hours. Survival rates were similar with CRESEMBA® and amphotericin B. Weighted all-cause mortality at day 42: 33% vs 41%, p=0.595}

• In the mucormycosis VITAL trial in adults CRESEMBA^® was associated with overall response rates similar to those reported for liposomal AmB³
  • At day 42, 11% (n=4/37) showed partial response
  • At the end of treatment, 31% (n=11/36) showed complete or partial response

Paediatric populations
CRESEMBA® achieves good response and survival rates in the paediatric population⁴
Explore the study results for CRESEMBA (isavuconazole) as a treatment for invasive fungal diseases in paediatric patients.

^{a. Dose selection informed by data from preceding paediatric phase 1 study. Doses for the two administration routes (oral and IV) were equivalent on a mg:mg basis. Patients received a loading regimen of 10 mg/kg isavuconazonium sulfate (equivalent to 5.4 mg/kg isavuconazole). b. End of treatment was defined as receiving once-daily maintenance dose of 10 mg/kg isavuconazonium sulfate (equivalent to 5.4 mg/kg isavuconazole), (up to a maximum of 372 mg isavuconazonium sulfate (equivalent to 200mg isavuconazole)) for up to 84 days (invasive aspergillosis) or 180 days (mucormycosis), or until a successful response was achieved, whichever occurred first. EORTC/MSG, European Organization for Research and Treatment of Cancer/Mycoses Study Group; IV, intravenous; PK, pharmacokinetic; q8h±2 , every 8 hours (±2 hours).}
In the paediatric registration trial, CRESEMBA achieved survival rates of ~90% in children from 1 year of age at day 84.⁴

• All-cause mortality at day 84 was 9.7% (n=3/31)⁴
• Fatality rates in children were lower than in the SECURE trial (adult population at day 42, 20%)^4,2
• No deaths occurred while a patient was receiving study drug⁴

For long-term treatment beyond 6 months, the benefit-risk balance should be carefully considered^.1

Adult Populations

CRESEMBA® has an improved tolerability profile vs voriconazole, with fewer drug-related adverse events²

• In the SECURE trial, CRESEMBA® showed significant reductions in the frequency of azole-specific adverse events and lower rates of treatment discontinuation due to AEs vs voriconazole for the treatment of invasive aspergillosis.²

In the VITAL trial, the AE profile of CRESEMBA® for the treatment of mucormycosis was consistent with observations from the SECURE trial for the treatment of invasive aspergillosis. Only 16% (n=6/37) of patients with mucormycosis discontinued CRESEMBA® due to AEs.³

Paediatric Populations
CRESEMBA® is well tolerated by paediatric patients⁴

• CRESEMBA® has a similar safety profile across adult and paediatric patients^4,2
• In the paediatric registration trial, reported TEAEs and SAEs were broadly similar in nature and frequency to those reported in adults with invasive fungal disease in the SECURE study^4,2
• CRESEMBA® was well tolerated in children from 1 year of age

At day 42, 6.5% of paediatric patients discontinued treatment due to drug-related TEAEs.⁴Although the overall proportion of children who experienced TEAEs was 93.5%, less than a third of these were drug-related,^aand most were mild or moderate in intensity.⁴

Summary of TEAEs and treatment withdrawls in children from 1 year of age

a. Drug-related events, as assessed by the investigator, were those with a reasonable possibility that the event may have been caused by the study drug; if any other relationship was missing, the event was also considered as drug-related.⁴

Adult Populations
The dosage of CRESEMBA® for adult patients is fixed and simple, with a once-daily maintenance regimen and no need to adjust by weight.¹ 
With high oral bioavailability (98%), the IV and oral formulations can be used interchangeably¹ which can help facilitate the switch from hospital to home care.

• For long-term treatment beyond 6 months, the benefit-risk balance should be carefully considered¹

Paediatric Populations

• Dosing can be tailored to your patient based on their weight¹
• CRESEMBA® comes in both IV and oral formulations,¹ which may facilitate the transition from hospital to home care.⁵
• 40 mg CRESEMBA® capsules are now available to facilitate oral dosing in children from 6 years of age.¹
• No dose recommendation can be made for paediatric patients from 1 year and older with hepatic or renal impairment, as no relevant data are available.¹
• Paediatric patients from 6 years to less than 18 years of age and with a bodyweight at least 32 kg may receive CRESEMBA®100 mg capsules. However, the use of CRESEMBA® 100 mg capsules has not been studied in paediatric patients.¹

CRESEMBA® has a once-daily maintenance dosing regimen in children, with a choice of either IV formulation from 1 year of age or hard capsules from 6 years.^a

• For long-term treatment beyond 6 months, the benefit-risk balance should be carefully considered.¹