The STOP2030 Consortium is pleased to announce that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive scientific opinion for the fixed-dose combination (FDC) of albendazole and ivermectin for soil-transmitted helminths and lymphatic filariasis infections for adult, teenagers and children aged 5 years and older.

The favourable evaluation by EMA is in accordance to the Article 58 (EU-M4All) procedure for high-priority medicines for human use intended for markets outside the European Union. The publication of this opinion marks a significant milestone for the STOP2030 project, as it will streamline the FDC’s prequalification by WHO and support the consideration of regulatory agencies in endemic countries worldwide.

The application for this scientific opinion was submitted by Laboratorios Liconsa, the Spanish pharmaceutical company that developed and produces the FDC and leads the STOP2030 Consortium. The favourable evaluation is based on the results of several clinical trials, with the ALIVE study being of particular importance as it demonstrated the safety of the FDC and its superior efficacy against Trichuris trichiura compared to albendazole monotherapy. It can control more parasite species while maintaining the one-tablet-per-person logistics common in current MDA campaigns.

“The development of Ivermectin/albendazole holds a high public health value as it will bring concrete advantages to the effectiveness of mass administration programmes in countries where these diseases are endemic”, explained EMA in a news release with regards to the CHMP’s favourable evaluation. “It will help reduce the risk of incorrect dosage, improve adherence, and reduce manufacturing and transport costs. Ultimately, this will allow more people to be treated”.

“The positive scientific opinion of EMA is an important validation of 15 years of innovations and collaborative work”, said Alejandro Krolewiecki, Principal Investigator of the STOP2030 project, “and it brings us closer to our goal of providing endemic countries with a pharmacological tool that assists them in achieving their elimination targets for neglected tropical diseases”.

The STOP2030 Consortium’s goal is to gather additional evidence on important implementation aspects that can take the FDC to mass adoption. The REALISE study, that will evaluate the safety of the FDC in a mass administration context, is mere months away from starting the recruitment of around 20,000 patients in Ghana and Kenya. It will be followed by a clinical trial to evaluate the FDC’s acceptability, feasibility and cost-effectiveness for which formative studies have already been successfully carried out.

I am delighted that the work of the STOP Consortium, supported by the EDCTP programmes since 2017, and the strong partnerships forged with Mundo Sano and Liconsa, has resulted in this positive scientific opinion from EMA. Research on both neglected infectious diseases and in underserved populations has been among the key priorities for EDCTP. Successful development and access to a suitable paediatric treatment for parasitic worm infections – through this global public-private partnership – will be a tangible contribution towards the Sustainable Development Goals by ensuring that school-aged children are not left behind.

At Global Health EDCTP3, we felt it important to support the implementation of this new treatment and I look forward to seeing more results generated as part of the STOP2030 project, strengthening the data package in real-life settings.

Michael Makanga. Executive Director. Global Health EDCTP3

We at Mundo Sano are thrilled to receive this positive scientific opinion from EMA. It reinforces our belief that collaboration is the best strategy for tackling the complexities of global health. Effective collaboration between the private and public sectors and among other disciplines is vital for achieving and sustaining programs. It’s also important to recognise the value of perseverance. The achievement we celebrate today began nearly 15 years ago with an initial pilot project in Salta, Argentina. Since then, we have scaled up and added partners, which made this amazing accomplishment possible.

At this moment, we want to express our gratitude to everyone involved. This includes our partners, the researchers from various consortiums, Liconsa Laboratory that produced this innovative tablet, and EDCTP for supporting projects like this one. Each of them played a vital role in this success.

Silvia Gold. President. Fundación Mundo Sano

We are very proud to be part of the STOP Consortium and to see the progress of the STOP2030 results. This joint effort speaks volumes about our approach to work and project management at Insud Pharma and through our Liconsa laboratories in Spain. From the beginning, we have advocated for public-private collaboration as the best way to preserve and promote our group’s commitment to supporting initiatives that ensure access to healthcare and have a real impact. Science is also about providing access, which is why we are very proud of this collaboration between Liconsa, EDCTP, and, of course, Mundo Sano foundation.

Lucas Sigman. CEO. Insud Pharma (Laboratorios Liconsa)