Supyra® becomes the second seasonal malaria chemoprevention medicine to be prequalified.
MMV welcomes the WHO prequalification of S Kant Healthcare’s dispersible sulfadoxine-pyrimethamine plus amodiaquine (SPAQ) product Supyra® for seasonal malaria chemoprevention (SMC). Providing a second manufacturer of quality-assured, child-friendly SPAQ provides both increased supply and greater security of supply for this important protective medicine.
The WHO recommends SMC to protect children aged 3 months to 5 years in areas of seasonal malaria transmission in the Sahel region of sub-Saharan Africa. The medicine used for SMC, SPAQ, is administered once per month (over three consecutive days) throughout the rainy season, and, in clinical trials, has demonstrated a 75% reduction in the incidence of all malaria.
Owing to the effectiveness of SMC, its implementation has significantly expanded over recent years. In 2015, 3.6 million children were protected and by 2020 that number increased to 33 million across 13 countries. During this time, there was only one WHO Prequalified supplier, creating a vulnerability in product supply. The COVID-19 pandemic highlighted the general fragility of global medical supply chains, emphasizing the importance of having multiple suppliers.
With funding from Unitaid, MMV worked with S Kant to develop a child-friendly, palatable and affordable formulation which was submitted to WHO prequalification in July 2018. This is important since WHO’s Prequalification of Medicines Programme is recognized as a legitimate “stamp of approval” by donor-funded procurement agencies; prequalification confirms that medicines have met acceptable standards of quality, safety and efficacy. Meanwhile, the medicine was reviewed by the Global Fund Expert Review Panel, enabling its procurement, while regulatory/WHO prequalification review was ongoing.
“We are delighted to see S Kant reach this important milestone for their SPAQ product,” said George Jagoe, MMV EVP for Access and Product Management. “In the past, we have witnessed how manufacturing disruptions have destabilized medicinal supply chain security and threatened countries’ ability to prevent and treat malaria. The prequalification of S Kant’s product will help significantly reduce the risk that such disruptions could derail the critical intervention of preventing malaria in children via the high-impact deployment of SMC.”
“Supyra is the first S Kant medicine that has become WHO prequalified and as such it is very close our hearts,” said Bharat Shah, S Kant’s Managing Director. “S Kant supports MMV’s drive to implement SMC and is absolutely determined to make sure that there is no shortage of these products, so that vulnerable populations can be protected from getting malaria.”