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Thai Food and Drug Administration (Thai FDA) Public Assessment Report New Medicinal Products

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Thai Food and Drug Administration (Thai FDA) Public Assessment Report New Medicinal Products Thai Food and Drug Administration (Thai FDA) Public assessment report New medicinal products Cresemba® 100 mg hard capsules Isavuconazole E-identifier number: e6200003 Registration number: 1C 15072/63 (NC) Approval date: 9 April 2020 Cresemba® powder for concentrate for solution for infusion 200 mg/vial Isavuconazole E-identifier number: e6200004 Registration number: 1C 15073/63 (NC) Approval date: 9 April 2020 Applicant: Pfizer (Thailand) Limited Product team leader: Worasuda Yoongthong Co-product team leader: Suchat Arammalueangsi Start of the procedure: 25 January 2019 Date of this report: 21 December 2020 TABLE OF CONTENTS 1. Recommendation ................................................................................... 4 2. Executive summary ............................................................................... 4 2.1. Problem statement ............................................................................................. 4 2.2. About the product .............................................................................................. 5 2.3. The development programme/compliance with Thai FDA guidance/scientific advice .... 5 2.4. General comments on compliance with GMP, GLP, GCP ........................................... 5 2.5. Type of application and other comments on the submitted dossier ........................... 5 3. Scientific overview and discussion ........................................................ 5 3.1. Quality aspects .................................................................................................. 5 3.1.1. Introduction .................................................................................................... 5 3.1.2. Active Substance ............................................................................................. 6 3.1.3. Finished Medicinal Product [Hard Capsule] .......................................................... 6 3.1.4. Finished Medicinal Product [Powder for Concentrate for Solution for Infusion] ......... 7 3.2. Non clinical aspects ............................................................................................ 7 3.2.1. Pharmacology ................................................................................................. 7 3.2.2. Pharmacokinetics ............................................................................................ 9 3.2.3. Toxicology .................................................................................................... 12 3.2.4. Discussion on non-clinical aspects .................................................................... 21 3.2.5. Conclusion on non-clinical aspects ................................................................... 21 3.3. Clinical aspects ................................................................................................ 22 3.3.1. Tabular Listing of All Clinical Studies ................................................................ 22 3.3.2. Pharmacokinetics .......................................................................................... 28 3.3.3. Pharmacodynamics ........................................................................................ 36 3.3.4. Discussion on clinical pharmacology ................................................................. 42 3.3.5. Conclusions on clinical pharmacology ............................................................... 43 3.3.6. Clinical efficacy and safety .............................................................................. 44 3.3.7. Discussion on clinical efficacy and safety .......................................................... 49 3.3.8. Conclusions on clinical efficacy and safety ........................................................ 49 3.3.9. Pharmacovigilance system and risk management plan ....................................... 49 4. Benefit risk assessment ....................................................................... 50 5. Conditions for marketing authorisation and product information ........ 50 5.1. Conditions for the marketing authorisation .......................................................... 50 5.2. Summary of product characteristics (SmPC) ........................................................ 50 5.3. Labelling ......................................................................................................... 50 5.4. Patient information leaflet (PIL) ......................................................................... 52 Cresemba® Public assessment report Rev 21 December 2020 Page 2/52 Administrative information Invented name of the medicinal product: CRESEMBA เครสเซมบา INN (or common name) of the active Isavuconazole (as isavucozonium sulfate) substance(s): ไอซาวูโคนาโซล Applicant: Pfizer (Thailand) Limited Applied indication(s): CRESEMBA is indicated in adults for the treatment of • Invasive aspergillosis • Mucomycosis in patients for whom amphotericin B is inappropriate Pharmaco-therapeutic group (ATC Code): (J02) Pharmaceutical form(s) and strength(s): 100 mg capsule, hard; 200 mg/vial powder for concentrate for solution for infusion Declarations This application includes an Active Substance Master File (ASMF): ☐ Yes ☐ No ☒ Not applicable ☐ The assessor confirms that proprietary information on, or reference to, third parties (e.g. ASMF holder) or products are not included in this assessment, including the Product Information, unless there are previous contracts and/or agreements with the third party(ies). ☐ The assessor confirms that reference to ongoing assessments or development plans for other products is not included in this assessment report. Whenever the above box is un-ticked please indicate section and page where confidential information is located (including the Product Information document) here: Cresemba® Public assessment report Rev 21 December 2020 Page 3/52 1. Recommendation Based on the review of the data and the Applicant’s response to the list of questions (LOQs) on quality, safety, efficacy, Thai FDA considers that the application for CRESEMBA indicated in adults for the treatment of • Invasive aspergillosis • Mucomycosis in patients for whom amphotericin B is inappropriate is approvable provided that the applicant commits to perform risk management plan as post authorisation measures to be reported back to Thai FDA within predefined timeframes. A preliminary list of such post- authorisation measures is in section 5.1 of this report. 2. Executive summary 2.1. Problem statement Invasive aspergillosis is a life-threatening infection that is seen predominantly in immunocompromised patients. Patients at greatest risk are those with prolonged neutropenia related to antineoplastic chemotherapy or hematopoietic stem cell transplantation (HSCT), those receiving immunosuppressants following solid organ transplants, advanced HIV infection and those given high doses of corticosteroids. The transmission of fungal spores to the human host is via inhalation and Aspergillus primarily affects the lungs, causing 4 main syndromes: allergic bronchopulmonary aspergillosis (ABPA), chronic necrotizing Aspergillus pneumonia (also termed chronic necrotizing pulmonary aspergillosis [CNPA]), aspergilloma, and invasive aspergillosis. The majority of human illness is caused by Aspergillus fumigatus and Aspergillus niger and, less frequently, by Aspergillus flavus and Aspergillus clavatus. Aspergillus may hematogenously disseminate beyond the lungs and the CNS, cardiovascular system, and other tissues may be infected as a result. Invasive aspergillosis is treated with systemic antifungal agents, such as polyenes (Amphotericin B), mould active triazoles (voriconazole, itraconazole, posaconazole) and echinocandins (caspofungin, micafungin, and anidulafungin). Certain conditions of invasive aspergillosis warrant consideration for surgical resection of the infected focus. Despite the current available antifungal therapies (AFTs) for invasive aspergillosis IFD is still associated with high mortality rates (30-40% in treated and 95% in untreated patients). Mucormycosis is extremely rare and refers to several different diseases caused by infection with fungi in the order of Mucorales. Rhizopus species are the most common causative organisms. Mucoraceae are ubiquitous fungi that are commonly found in soil and in decaying matter. Rhizopus can be found in moldy bread. Most humans are exposed to these organisms on a daily or weekly basis. The major route of infection is via inhalation of conidia; other routes include ingestion and traumatic inoculation. They rarely cause disease because of the low virulence of the organisms; instead, they mainly affect immunocompromised patients. Patients with uncontrolled diabetes mellitus, especially with ketoacidosis, are at high risk. Patients with cancer—especially those who are neutropenic and receiving broad- spectrum antibiotics—as well as individuals receiving immunosuppressive agents—including oral or intravenous steroids and tumor necrosis factor (TNF)–alpha blockers—are at risk. In addition, hematologic cancer patients with opportunistic herpetic infections (e.g., cytomegalovirus) and graft versus host disease are at increased risk. Most mucormycosis infections are life-threatening. Severe infection of the facial sinuses, which may extend into the brain, is the most common presentation. Pulmonary, cutaneous, and gastrointestinal (GI) infections are also recognized. Rhinocerebral disease causes significant morbidity in patients who survive, because treatment usually requires
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