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GSK PLC on Monday said the US Food & Drug Administration has approved its Priorix vaccine for active immunisation for the prevention of measles, mumps and rubella in individuals of 12 months of age and older.
The London-based pharmaceutical company said Priorix is currently licenced in more than 100 countries worldwide, including all European countries, Canada, Australia and New Zealand.
More than 800 million doses of the treatment have been distributed to date, the FTSE 100 listed firm added.
The safety of Priorix was evaluated in six clinical studies, in which a total of 12,151 participants received at least one dose of it. Its efficacy was demonstrated based on immunogenicity data compared to the comparator vaccine.
Measles, mumps and rubella are acute and contagious viral diseases that can also lead to serious conditions including meningitis and hearing loss.
‘We're proud to make Priorix available in the US for the first time, adding a choice for providers to help protect patients against these highly contagious diseases and to further strengthen offerings in our paediatric vaccine portfolio,’ said Judy Stewart, head of US Vaccines for GSK.
GSK shares were trading marginally lower in London on Monday morning at 1,707.26 pence each.
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