The U.S. Food and Drug Administration (FDA) has approved depemokimab-ulaa (Exdensur) as an add-on treatment for people 12 and older living with severe asthma. Specifically, the medication is indicated for severe asthma considered to be eosinophilic. Taken twice per year, the drug reduced annual asthma attacks between 48 percent and 58 percent compared with a placebo (inactive treatment) in clinical trials.

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What Is Depemokimab and How Does It Work?

Depemokimab is the first (and so far only) twice-yearly biologic for severe asthma approved in the U.S. It’s designed for people whose asthma is driven by high levels of eosinophils — a type of white blood cell linked to inflammation and asthma attacks. Eosinophilic asthma is relatively rare, accounting for only about 5 percent of adult asthma cases. However, eosinophilic asthma accounts for about half of all severe asthma cases.

Depemokimab works by targeting and reducing this type of inflammation, helping to prevent asthma symptoms and attacks over the long term.

What Did the Studies Find?

The FDA approved depemokimab based on the results of two phase 3 clinical trials. These studies included more than 700 people with severe asthma who continued to have symptoms despite using standard treatments like inhaled corticosteroids and at least one other asthma medicine.

People who received depemokimab had:

• A reduction of asthma attacks by 48 percent in one trial and 58 percent in the other over 52 weeks, compared with those taking placebo
• Fewer asthma attacks leading to hospitalizations or emergency room visits — 1 percent to 4 percent for those taking depemokimab compared with 8 percent and 10 percent for the placebo
• A 72 percent overall reduction in severe attacks requiring hospital care, based on pooled data from both studies

These benefits were seen with just two doses of depemokimab per year, given alongside other asthma medications.

Side Effects

Across the clinical trials, people taking depemokimab experienced side effects at a rate and severity similar to those taking placebo. This suggests the medicine was generally well tolerated.

According to the drug’s prescribing information, common side effects include:

• Upper respiratory tract infection
• Hay fever
• Flu symptoms
• Joint pain
• Sore throat

Rare but serious side effects may include hypersensitivity reactions, including anaphylaxis (a severe allergic reaction).

As with all new treatments, it’s important to talk with your doctor about potential risks and benefits before starting depemokimab.

Why This Approval Matters for Asthma Treatment

For people living with severe asthma, frequent symptoms and attacks can make daily life difficult and sometimes lead to emergency care or hospitalization. While biologic medicines have helped some people better control severe asthma, these drugs often require injections every one to two months. Depemokimab is the first biologic option with a twice-yearly dosing schedule, which may make it easier for people to stick with treatment.

If you’re living with severe asthma and aren’t finding relief from your current treatment plan, speak with your healthcare provider about what options may be available. Together, you can develop a personalized plan that meets your specific treatment goals.

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On MyAsthmaTeam, people share their experiences with asthma, get advice, and find support from others who understand.

Have you tried a biologic treatment for asthma? Let others know in the comments below.