Ahmedabad-based Zydus Lifesciences has received prequalification approval from the World Health Organization (WHO) for the production of the active pharmaceutical ingredient (API) Miltefosine, used to treat Leishmaniasis, commonly known as Kala Azar. This approval will increase the availability of the drug worldwide.
Leishmaniasis is a parasitic disease transmitted by the bite of infected sandflies. It primarily affects impoverished populations and is linked to poor living conditions, malnutrition, and a compromised immune system. According to the WHO, Leishmaniasis manifests in three primary forms: cutaneous (CL), visceral (VL), and mucocutaneous (MCL). While CL is the most prevalent form, VL is the most severe and can be fatal if left untreated. An estimated 700,000 to 1 million new CL cases and 30,000 new VL cases occur annually.
In 2018, 92 and 83 countries were considered endemic or had reported CL and VL cases, respectively. Over 1 billion people reside in areas where Leishmaniasis is prevalent and are at risk of infection.
Zydus Lifesciences' Vaccine Technology Centre (VTC) is actively developing a vaccine for Leishmaniasis. In 2015, Etna Biotech, Zydus' R&D subsidiary, partnered with the US-based National Institute of Allergy and Infectious Diseases to develop a vaccine for visceral leishmaniasis (VL).