Eli Lilly and EVA Pharma have announced approval from the Egyptian Drug Authority for the human insulin glargine injection to treat type 1 and type 2 diabetic patients.
EVA Pharma manufactures the injection in partnership with Lilly.
The collaboration, which began in 2022, aims to provide quality, affordable insulin to a minimum of one million type 1 and type 2 diabetic individuals in low to middle-income countries (LMICs) annually, predominantly in Africa.
In under two years, EVA Pharma then established a new biologics manufacturing facility, completed stability testing and finalised insulin formulations, along with gaining the regulatory approval secured for the insulin injection locally.
Lilly has been instrumental in supplying its active pharmaceutical ingredient (API) for insulin at a low cost and offering technology transfer to EVA. This has enabled the local formulation, filling and finishing of insulin vials and cartridges.
In parallel, EVA has submitted its insulin injection for local regulatory approval. The collaboration also includes efforts to achieve World Health Organization (WHO) pre-qualification for insulin injection, which would affirm the high-quality standards of EVA’s medicines as set by WHO.
The initiative aligns with the Lilly 30x30 goal, which aspires to enhance access to quality healthcare for 30 million people in resource-limited settings every year by 2030.
Lilly International president and executive vice-president Ilya Yuffa stated: "For more than a century, Lilly has been at the forefront of diabetes care, offering innovative solutions that make life better for people around the world.
"Our collaboration with EVA Pharma furthers our commitment to providing sustainable and accessible medicines worldwide. “
In September 2024, Lilly also agreed to license baricitinib manufacturing know-how to EVA, enabling the supply of treatments for immunological diseases in 56 LMICs across Africa.
In a separate development, the China National Medical Products Administration (NMPA) approved Lilly’s Kisunla (donanemab-azbt, 350 mg/20 mL every four weeks injection for IV infusion) for adults with early symptomatic Alzheimer's disease, including those with mild cognitive impairment and mild dementia stage who have confirmed amyloid pathology.
The NMPA application was supported by data from the Phase III TRAILBLAZER-ALZ 2 trial.
