Fosravuconazole treatment in eumycetoma: corroborating study outcomes, preparing for access
  • RFP Year
  • Awarded Amount
  • Disease
    NTD (Mycetoma)
  • Intervention
  • Development Stage
  • Collaboration Partners
    Eisai Co., Ltd. ,  Drugs for Neglected Diseases initiative
  • Past Project

Introduction and Background of the Project


Mycetoma is a chronic infection that causes severe disability. Until recently, limited treatment options available showed poor efficacy, even after 12 months of treatment. In addition, data on safety are limited and the prohibitive cost of available drugs often resulted in incomplete treatment with a high chance of recurrence.

Fosravuconazole, an oral azole developed for onychomycosis by Eisai Co., Ltd. (Eisai), Japan, was shown to have potent in vitro activity against the most common of the causative agents of eumycetoma, Madurella mycetomatis. Drugs for Neglected Diseases initiative (DNDi), in partnership with Eisai and the Mycetoma Research Center (MRC), Sudan, implemented the first randomized clinical trial (RCT) for patients with eumycetoma in Sudan. This recently completed RCT showed generally good cure rates. Fosravuconazole is considered to have additional favorable characteristics such as once a week dose regimen.


Project objective

This project aims to bridge the gap between outcome of the fosravuconazole’s RCT with limited data, and provide access to fosravuconazole for treatment of eumycetoma in Sudan.

1. Registration

Objective: to make fosravuconazole accessible to patients in Sudan until registration process.

2. Implementation and preparing for access

i. Cohort study
Objective: to treat a cohort of 100 patients with fosravuconazole under supervision of the MRC, collecting additional data on safety and treatment outcome.

ii. Development of a strategic plan
Objective: to develop a strategic plan for mycetoma. To understand the needs and opportunities in other endemic areas (e.g. India and Senegal), field visits and expert meetings will guide and outline the next steps for use of fosravuconazole as a monotherapy or potentially in combination therapy in severe eumycetoma.


Project design

1. Registration

Based on the results of the RCT, preparations for the application for approval in Sudan will be undertaken. Fosravuconazole is registered in Japan for indication of onychomycosis.

2. Implementation and preparing for access

i. Cohort study
The cohort study provides early access to treatment with fosravuconazole for patients with eumycetoma in a controlled manner, whilst monitoring treatment outcome and patient safety. Approximately 100 patients enrolled in the cohort study will be treated with weekly doses of fosravuconazole at 200 mg for 12 months in combination with surgery at 6 months.

ii. Development of a strategic plan
A strategic plan will be developed by the following steps. Post-hoc analyses of the RCT will be performed to evaluate all factors that have influenced outcomes. Expert meetings will be organized to discuss the study data and outcomes, and how to assess new drugs that have been developed in the context of other fungal diseases. Field visits to other important eumycetoma endemic areas such as India and Senegal will be conducted to assess current practice and local needs for treatment while also collecting epidemiological data to assess burden of the disease.

How can your partnership (project) address global health challenges?

Mycetoma is among the most neglected tropical diseases (NTDs) as targeted in the WHO NTDs road map 2021-2030. It is a slow-growing infection that causes severe disabilities and is typically associated with poverty and affects poor people in rural areas with limited access to health care. Disfigurement and disability can lead to stigma and social discrimination, placing a heavy burden on communities and health services in affected areas. An effective control of mycetoma is fundamental to achieve the United Nations Sustainable Development Goals (SDGs), especially SDG target 3.3., which calls for ending the epidemics of NTDs and other infectious diseases by 2030. This project will provide a solution to the critical gaps and address the needs of patients suffering from this woefully neglected disease.

What sort of innovation are you bringing in your project?

There was no consensus on treatment for eumycetoma as no drugs have been studied in an RCT, except for fosravuconazole and itraconazole in the recently completed RCT. Fosravuconazole is expected to be a significant improvement considering the important medical needs of alternative therapies for mycetoma and advantages of fosravuconazole such as its once weekly administration, its favorable safety profile and it can be taken without food or drink, in addition to the favorable results shown by the recently completed RCT.

Role and Responsibility of Each Partner

DNDi will have overall responsibility for project management and coordination.

Eisai and DNDi will jointly engage in discussions with the regulatory authorities (NMPB) in Sudan through a contracted regulatory agent regarding registration and prepare a dossier necessary for registration in Sudan.

DNDi will conduct the cohort study in collaboration with the MRC and will be responsible for data entry and data analysis to produce study reports. Eisai will make the study drug of fosravuconazole available to DNDi.

The outstanding issues and needs activity will be done jointly by DNDi and Eisai.