An advisory panel of the Food and Drug Administration (FDA) today voted to approve the use of a biologic medication to treat asthma, a chronic condition that makes it difficult to breathe.

The FDA generally follows the recommendations of its advisory panels.

The injectable drug — Nucala (mepolizumab), made by GlaxoSmithKline — would become just the second biologic drug to treat asthma, which affects nearly 19 million adults in the United States.


Xolair (omalizumab) secured the FDA’s approval in 2003. More such drugs, which target particular aspects of the body’s over-active immune response, are expected to follow in the coming years.

To qualify for Nucala, patients would have to have severe, or uncontrolled allergic asthma. They also must be over 18 years old. Lab tests would also have to demonstrate elevated counts of white blood cells, called eosinophils, that the drug would block.

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Severe Asthma Is Frightening

About half of asthma patients have allergic asthma, and 1 in 10 asthma cases is considered severe.

Severe asthma is “almost like a different disease” than moderate or mild asthma, according to Mike Tringale, senior vice president at the Asthma and Allergy Foundation of America (AAFA).

About half of severe asthma patients end up in the emergency room or even hospitalized each year, often several times a year. Many so fear an attack that they are essentially homebound.

Nucala reduces the annual chance of an ER visit by roughly half, according to the clinical trials data presented to the FDA panel.

“The severe patient will still need their daily inhaler, their rescue medication, but if finally once and for all they can get their asthma under control, that’s a very positive outcome,” Tringale said.

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Some May Not Be Able to Afford New Drug

Patients’ enthusiasm for Nucala and drugs like it will depend on what kind of coverage insurers offer. Nucala is injected under the skin once every four weeks and is likely to be expensive, which sometimes leads plans to limit coverage.

“It’s no secret that the biologics are the most costly therapies in the system,” Tringale said. Insurance plans are “inconsistent” in their offerings for these drugs.

But the cost of caring for U.S. asthma patients through their nearly 2 million emergency room visits per year isn’t cheap, either. The AAFA estimates that asthma costs $56 billion a year to manage.

GlaxoSmithKline had proposed use of the drug for severe asthma sufferers over age 12, but the FDA panel recommended use only in adults over age 18.

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