GSK PLC on Monday said its Arexvy offering received a ‘positive opinion’ from the European Medicines Agency’s Committee for Medicinal Products for Human Use.
The London-based pharmaceutical company said the CHMP gave a promising assessment of the drug in the treatment of 50-to-59-year-old people who are at increased risk of respiratory syncytial virus disease.
If it is approved, Arexvy will be the first EU jab to treat RSV in that age group. A decision on EU marketing authorisation for this population is expected by September.
‘Today’s positive opinion is the first time that an indication for adults aged 50-59 has been recommended by CHMP for a RSV vaccine, one of the final steps prior to the extension of the marketing authorisation by the European Commission,’ GSK said.
Separately on Monday, GSK said it reached a confidential settlement with Ronald Kimbrow on a case he filed in Illinois state court, regarding the heartburn drug ranitidine, otherwise known as Zantac. GSK said it does not admit any liability in the settlement and noted the case will now be dismissed.
‘Following the 16 epidemiological studies looking at human data regarding the use of ranitidine, the scientific consensus is that there is no consistent or reliable evidence that ranitidine increases the risk of any cancer,’ GSK said.
Zantac was a heartburn drug that was pulled off the market in 2020 at the request of the US Food & Drug Administration, after low levels of a ‘probable carcinogen’ were found in samples. The carcinogen, known as NDMA, is not harmful in very small amounts. However, tests showed that there were excessive quantities of NDMA in ranitidine. Multiple litigations have followed.
GSK shares were 0.9% higher at 1,566.50 pence each on Monday morning in London.
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