Zydus Lifesciences gets WHO nod for API used in kala-azar treatment

More than 1 billion people live in areas endemic for leishmaniasis or Kala Azar and are at risk of infection

Ahmedabad-headquartered Zydus Lifesciences has received the World Health Organisation’s (WHO’s) prequalification approval for the active pharmaceutical ingredient (API) called Miltefosine, to treat Leishmaniasis or Kala Azar, the company said.

This will enable larger access to the drug globally.

Leishmaniasis is caused by protozoan parasites which are transmitted by the bite of infected female phlebotomine sandflies.

The disease affects some of the world’s poorest people and is associated with malnutrition, population displacement, poor housing, a weak immune system, and a lack of financial resources.

According to WHO, there are three main forms of the disease: cutaneous leishmaniasis (CL), visceral leishmaniasis (VL), also known as kala-azar, and mucocutaneous leishmaniasis (MCL).

CL is the most common form, VL is the most severe form and MCL is the most disabling form of the disease. VL, if left untreated, causes death in more than 90 per cent of cases. An estimated 700,000 to 1 million new cases and an estimated 30,000 new cases of VL occur annually.

In 2018, 92 and 83 countries were considered endemic for or had previously reported cases of CL and VL respectively.

At present, more than 1 billion live in areas considered endemic for leishmaniasis and are at risk of infection.

It may be noted that the Vaccine Technology Centre (VTC) of Zydus Lifesciences, which has two R&D centres -- Catania, Italy and another in Ahmedabad -- has been developing a vaccine for Leishmaniasis.

In 2015, Zydus said its R&D subsidiary Etna Biotech will collaborate with the US-based National Institute of Allergy and Infectious Diseases to develop a vaccine against visceral leishmaniasis (VL), known as Kala Azar in India.

Meanwhile, the stock of pharma major Zydus Lifesciences hit lifetime highs last week and gained 40 per cent over the past three months. More than half the gains for the stock came in the previous month.