Orchid Pharma to produce GSK and Shionogi’s antibiotic for global access

Orchid Pharma, GSK, Shionogi, cefiderocol, antibiotic, license, global access

Orchid Pharma, a subsidiary of India’s Dhanuka Labs, has secured a sublicense to manufacture the antibiotic cefiderocol. This development is crucial in addressing Gram-negative bacterial infections that may have developed resistance to other antibiotics. Cefiderocol received FDA approval in 2019, followed by European Medicines Agency approval in 2020. Notably, it holds a coveted spot on the World Health Organization’s Model List of Essential Medicines.

Facilitating this access initiative are two prominent organizations: the Global Antibiotic Research and Development Partnership and the Clinton Health Access Initiative, both recognized for their commitment to enhancing healthcare on a global scale. This collaboration, initiated in 2022, is primarily focused on making this vital antibiotic available to low- and middle-income countries where access to such medications can be limited.

As part of this agreement, Orchid Pharma is mandated to submit the product for evaluation under the WHO medicines pre-qualification program. This designation carries significant advantages, including a streamlined registration process, reducing the time required for national regulatory approvals to a mere 90 days in participating countries.

The urgency of this effort cannot be overstated. Antimicrobial resistance (AMR) poses a grave threat to global health, with at least 1.27 million deaths attributed to AMR in 2019, as reported in The Lancet. The World Health Organization warns that without decisive action, more than 10 million lives per year could be jeopardized by AMR by the year 2050.

It’s worth noting that the development of cefiderocol was a collaborative effort between GSK and Shionogi. In a remarkable display of commitment to global health, GSK has decided to forego royalties from the sales of this vital medicine in low- and middle-income countries, according to Shionogi.

This endeavor represents a beacon of hope in the fight against antibiotic-resistant infections, where access to effective treatments is not just a matter of healthcare but a critical step in preserving countless lives worldwide. Orchid Pharma’s commitment to manufacturing cefiderocol is a significant stride towards ensuring that this life-saving antibiotic reaches those who need it most.

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