Geneva, 3 April 2023 – GARDP welcomes the World Health Organization’s (WHO) invitation to manufacturers to submit an application to develop the antibiotic, cefiderocol, which is used to treat multidrug-resistant bacterial infections.

This marks the first time the WHO Prequalification of Medicines Programme (PQP) has included multidrug-resistant bacterial infections in its work.

The invitation to submit an Expression of Interest to manufacture cefiderocol was made by the PQP to support efforts to increase affordability and access to treatment of multidrug-resistant bacterial infections. The WHO’s prequalification process assesses the quality, safety and efficacy of medicinal products.

Once a manufacturer applies, it needs to demonstrate that the product and manufacturing standards meet WHO-recommended standards. If successful, cefiderocol will be included in the list of prequalified medicinal products that UN organizations and others could consider procuring.

Cefiderocol was recently included on the WHO’s first-ever list of priority antibiotics to be developed for use in infants and children because of its efficacy against multiple pathogens prioritized by WHO as posing the greatest threat to health. Cefiderocol is also included in the WHO Model List of Essential Medicines. These contain medications that address the priority health care needs of a population and are safe and effective.

In 2022, GARDP was granted a license by Shionogi, which produces cefiderocol, to develop, manufacture, and commercialize the antibiotic through sub-licensees in 135 countries.