(Reuters) – GlaxoSmithKline drug Nucala has won a key recommendation from a European Medicines Agency (EMA) panel for use in the treatment of children with severe asthma, the company said in a statement on Friday.
The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended Nucala for use as an add-on treatment for severe refractory eosinophilic asthma in pediatric patients aged six up to 17 years, it said.
While final approvals are up to the European Commission, it generally follows the CHMP’s recommendation and endorses them within a couple of months.
If approved, Nucala – chemically known as Mepolizumab – would be the first targeted biologic therapy for the treatment of severe eosinophilic asthma in pediatric patients in Europe, GSK said.
A U.S. Food and Drug Administration expert panel on Wednesday did not support approval of Nucala in treating a disease that limits airflow to the lungs.
The panel found that the drug, which is already approved for treating severe asthma patients, was safe but that it did not demonstrate efficacy for a new indication. FDA staff reviewers earlier raised doubts as to whether the data GSK submitted provided evidence of the drug’s efficacy.
GSK said then that it would work with the agency to address its concerns.
The FDA is reviewing Nucala for reducing a sudden worsening of symptoms of chronic obstructive pulmonary disease, or COPD. While the FDA is not obliged to follow the advice of its experts, it generally does.
Reporting by Noor Zainab Hussain in Bengaluru; Editing by Jan Harvey