WASHINGTON -- A novel drug targeting interleukin-5, mepolizumab (Nucala), is approved for treating asthma in patients 12 and older with a history of severe exacerbations while on conventional maintenance therapy, .
In so doing, the agency went against one of its own advisory committees, which voted in June not to recommend the drug's approval in adolescents after determining that there was inadequate evidence of safety in this population. The committee did back approval in adults.
The FDA's approval announcement didn't indicate why it decided to overrule the committee on the adolescent indication.
Mepolizumab is given as a monthly subcutaneous injection, to be administered by a healthcare professional, the agency said. The approval also specifies that it's to be used as maintenance therapy in combination with other asthma medications.
Common adverse effects seen in the drug's trials include injection site reactions, back pain, and fatigue. A few cases of hypersensitivity reactions were recorded as well, along with herpes zoster infections.
Those trials demonstrated the drug improved asthma control compared with placebo when used in conjunction with conventional medications, with decreases in inhaled corticosteroid doses as well as lower rates of exacerbations requiring hospital admission or emergency treatment, the FDA said.
"This approval offers patients with severe asthma an additional therapy when current treatments cannot maintain adequate control of their asthma," said Badrul Chowdhury, MD, PhD, director of the Division of Pulmonary, Allergy, and Rheumatology Products in the FDA's Center for Drug Evaluation and Research, in a statement.