GlaxoSmithKline's new severe asthma treatment gets FDA approval
GlaxoSmithKline’s Nucala (mepolizumab) drug has received approval from the US Food and Drug Administration (FDA) for its Biologics License Application.
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The FTSE 100 pharmaceutical company revealed the news on Thursday.
Nucala has been approved as an add-on maintenance treatment for patients suffering from severe asthma with an eosinophilic phenotype.
It is the first marketing authorisation granted for mepolizumab anywhere in the world.
GSK Global Respiratory Franchise’s Eric Dube said it will allow the company to offer a “first-in-class biologic treatment for severe asthma patients whose condition is driven by eosinophilic inflammation”.
Dube said the company aims to offer Nucala to patients as soon as possible.