GSK’s Nucala (mepolizumab) Receives the US FDA’s Approval as First Biologic for Severe Eosinophilic Asthma in Children Aged 6-11yrs.

 GSK’s Nucala (mepolizumab) Receives the US FDA’s Approval as First Biologic for Severe Eosinophilic Asthma in Children Aged 6-11yrs.

GSK’s Nucala (mepolizumab) Receives the US FDA’s Approval as First Biologic for Severe Eosinophilic Asthma in Children Aged 6-11yrs.

Shots:

  • The US FDA’s approval follows the open-label study evaluating PK/PD and long-term safety of Nucala (40mg, SC) in children with severe eosinophilic asthma aged 6 to 11yrs. The approval is also supported by results of well-controlled studies assessing Nucala in adults and adolescents
  • The 52wks. long term study of Nucala in pediatric patients aged 6-11yrs. is similar to a safety profile in patients aged ≥12yrs.
  • Nucala (100mg, SC) is mAb targeting IL-5, approved as an add-on maintenance therapy for severe eosinophilic asthma patients aged ≥12yrs. in 2015. In Aug 2018, Nucala has received approval as an add-on treatment for severe eosinophilic asthma in patients aged 6-11yrs. in the EU

Click here to­ read full press release/ article | Ref: GSK | Image: Chicago Tribune

Tuba Khan

Tuba Khan is Senior Editor at PharmaShots. She is curious, creative, and passionate about recent updates and innovation in the Life sciences industry. She covers Biopharma, MedTech, and Digital health segments. Tuba also has an experience of digital and social media marketing and runs the campaigns independently. She can be contacted on tuba@pharmashots.com

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