Registration and access

The Consortium, in case of a successful outcome of the clinical program, aims to submit the Marketing Authorization Application in 2020 to have the product available in 2021, for launch in the first endemic countries in Africa. In parallel, the Marketing Authorization Application shall be submitted in Brazil (provided that no separate Phase III trial in Brazil is needed).

In collaboration with WHO and an Access Task Force of external experts, the Consortium has prepared an Access & Delivery plan, that will ensure timely registration, accessibility and affordability of the pediatric praziquantel treatment.

Registration

If the outcome of the clinical program is positive and no obstacles that might cause delay occur, registration of the new pediatric PZQ product is scheduled for beginning of 2020. Since its inception in 2012, the Consortium has been in close contact with various regulatory authorities, including endemic countries, to discuss the most optimal clinical trial program and registration route per the relevant local legislation.

Access and affordability

Once approved, the product will not be donated but made available on a not-for-profit basis. The rationale behind this is that the Consortium partners do not consider donation of PZQ-ODT a durable health solution, and are exploring alternative business models, including local manufacturing. Together with relevant stakeholders, we will examine ways of providing access to the new pediatric formulation in an affordable and sustainable manner.