(Alliance News) - GSK PLC on Tuesday said the World Health Organisation made it easier for its malaria vaccine Mosquirix to be rolled out while the US Food & Drug Administration is reviewing the firm's kidney disease drug, daprodustat.
Citing Mosquirix's new pre-qualification status by the WHO, GSK explained: "The WHO pre-qualification decision is a mandatory prerequisite for United Nations agencies, such as UNICEF, to procure the vaccine in partnership with Gavi, the Vaccine Alliance, and eligible countries.
"Pre-qualification for Mosquirix is the result of a rigorous regulatory process with the assessment of clinical, safety and technical data ensuring that the vaccine meets standards of quality, safety and efficacy, and is suitable for the target population".
The Brentford, London-based firm added that over one million children in Ghana, Kenya and Malawi have received at least one dose of Mosquirix, which is the first and only approved malaria vaccine globally.
Meanwhile, the FDA in the US will review the new drug application for GSK's anaemia of chronic kidney disease drug candidate, daprodustat. The advisory meeting will be on October 26.
GSK refers to positive results from a phase 3 clinical trial programme, which showed efficacy and safety data for treating anaemia "across the spectrum of chronic kidney disease." In March, the EU's European Medicines Agency started reviewing daprodustat. In Japan, the tablet is sold under the name Duvroq and was approved for patients with renal anaemia in June.
GSK shares were 0.7% lower at 1,347.96 pence each in London on Tuesday morning.
By Tom Budszus; tombudszus@alliancenews.com
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Glaxosmithkline (GSK)