GlaxoSmithKline PLC said the U.S. Food and Drug Administration expanded the approval of its Nucala medicine to treat children age 6 and older who have a severe form of asthma.
The U.S. regulator granted the marketing authorization for Nucala, also known as mepolizumab, as an add-on treatment for severe eosinophilic asthma in children 6 to 11 years old. This rare form of asthma is characterized by inflammation in the respiratory system caused certain white blood cells called eosinophils.
The approval is based on results from phase 2 study of the drug that showed Nucala was as safe to use in the 6 to 11 age group as it is for treating patients 12 years or older. Nucala was initially approved in 2015 for patients age 12 and older.
Nucala is approved in over 20 markets including the U.S. and Europe as an add-on maintenance treatment for patients with severe eosinophilic asthma. The FDA and the European Commission approved two new methods of administering the drug — autoinjector and a pre-filled safety syringe — in June and August, respectively.
The European regulator approved the drug as an add-on treatment for severe refractory eosinophilic asthma in children age 6 to 17 in August 2018.
Nucala generated £195 million from global sales in the second quarter of 2019, a 38.3% increase compared to the same period in 2018. GSK is facing competition in the market for severe asthma therapies from AstraZeneca PLC's Fasenra — whose U.S. sales came to $218 million in 2018 compared with Nucala's £341 million.
