GlaxoSmithKline PLC said the European Commission has approved two new methods of administering its asthma drug Nucala.
The European Medicines Agency's Committee for Medicinal Products for Human Use recommended the autoinjector and a pre-filled safety syringe delivery method for EU approval in May. Both options are to be administered by patients or caregivers once every four weeks after a healthcare professional decides it is appropriate.
The new marketing authorization is based on data from two late-stage studies, called NCT03099096 & NCT03021304. The ability to self-administer the drug through these methods was really popular among participants and 96% preferred these options over going to the clinic for the medication.
The U.S. Food and Drug Administration approved the use of autoinjector and pre-filled safety syringe to administer Nucala in June.
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, which is caused by high levels of white blood cells known as eosinophils.