Geneva – Cryptococcal meningitis is a severe fungal infection of the brain that causes around 15% of AIDS-related deaths globally. 75% percent of resulting deaths occur in sub-Saharan Africa, largely due to a lack of access to critical medicines. To fast-track commercialization of affordable, quality-assured supplies of a highly effective medicine used to treat cryptococcal meningitis, Unitaid has launched a call to generic manufacturers needing support to bring their product to market in low- and middle-income countries (LMICs).
Liposomal Amphotericin B (L-AmB) is the main drug used in the treatment of cryptococcal meningitis. Newly updated guidance from the World Health Organization now recommends treatment through a single high dose of L-AmB, making treatment simpler and causing fewer toxic side effects for the patient. However, new treatment guidance will only translate into lives saved if access to the drug is greatly improved.
Currently, although a 2018 agreement between Unitaid and the originator manufacturer Gilead secured access for the product in 116 LMICs at the price of US$ 16.25 per vial, uptake has been slow. So far, L-AmB is available at the negotiated price in 50 countries. Additional generic suppliers would help get vital, affordable, quality-assured products to countries more quickly.
With antigen screening methods adopted by many HIV programs in Africa and the prevalence of the infection now known in the key regions, access to simple, affordable treatments could significantly advance efforts to save lives threatened by the opportunistic infection.
“Cryptococcal meningitis is a leading cause of death among people with HIV. Recent advances in testing and treatment can only go so far if the medicine is unavailable in the places it is most needed. Through its work, Unitaid aims to quickly enable access to quality, affordable, life-saving medicine,” said Janet Ginnard, Director of Strategy at Unitaid.
Manufacturers with a generic formulation of L-AmB in advanced stages of development or ready for commercialization are invited to apply for technical, regulatory and/or financial support to quickly improve affordable, equitable access to life-saving medicine.
- More information is available here: Expression of interest (EOI) in receiving technical, regulatory and/or financial support to accelerate the commercialization of a quality assured product for Liposomal Amphotericin B (L-AmB)
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