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Real EKTERLY® (sebetralstat) patient Cari on a picnic Real EKTERLY® (sebetralstat) patient Cari on a picnic

Results
&
Side
Effects

CARI, real EKTERLY patient

Our clinical trial was designed with the HAE community in mind

The KONFIDENT trial is the largest on-demand clinical trial, which included 110 patients with type I or type II hereditary angioedema (HAE). Patients treated their attacks with either EKTERLY or placebo.

97 adults and 13 CHILDREN
(12 YEARS OF AGE AND OLDER)

  • Needle and pill bottle

    23% of people

    treated with both preventative and
    on-demand treatments

  • Hand holding a tablet medication

    77% of people

    treated with
    on-demand treatment only

People in the study had at least 2 or more attacks
in the 3 months leading up to the trial, including those
on preventative treatment.

EKTERLY provided
a fast start to
symptom relief

Median time to the beginning of symptom relief was:

1.8 hours*

WITH EKTERLY

vs

6.7 hours

WITH PLACEBO

*Analysis does not include attacks where response information was not provided. In product label, these attacks were included as having no response to treatment at 12 hours, shifting median to 2.0 hours.

Works for any
type of attack

The time it took for people to feel relief after taking EKTERLY was similar regardless of:

  • Age (12 years and older)
  • Whether or not they were on preventative treatment
  • Attack location and severity

Patients in the study used EKTERLY
to treat a wide range of attacks

Locations of HAE attacks on the body
Head, face,
neck 11.8%
Throat 2.2%
Torso 5.4%
Abdomen 45.2%
Genitals 4.3%
Arms, hands 28.0%
Legs, feet 24.7%

96% of attacks that were
effectively treated with
EKTERLY required
just 1 dose.

Ask your doctor if EKTERLY
could be
right for you.

Doctor Discussion Guide Download

Considering switching
your acute treatment?

Researchers looked back at the
clinical study to understand
patient satisfaction after
switching treatments.

Out of 1,089 attacks treated in the extended trial,

84%

of patients said they were satisfied
with EKTERLY as
their treatment.

Talk to your doctor to see if EKTERLY is right for you.

Download our Doctor
Discussion Guide.

The safety of EKTERLY was similar to placebo

Based on the total number of patients who treated 264 attacks:

SIDE EFFECT

EKTERLY 600 mg

n=93

PLACEBO

n=83
Headache,
no. (%) 		3 (3.2) 1 (1.2)
  • The most commonly reported
    side effect was headache
  • No one dropped out because
    of side effects

At KalVista, our commitment to the HAE community doesn't end when a trial does

That’s why we created KONFIDENT-S, an extension of the KONFIDENT trial. In this continued study, all participants receive EKTERLY—there’s no placebo—and because it’s open-label, each person knows exactly what treatment they’re getting. KONFIDENT-S gave patients continued access to EKTERLY, while also allowing us to confirm efficacy and gather long-term safety data for EKTERLY. It’s one more way we’re standing beside this community—every step of the way.

IN THE KONFIDENT-S TRIAL

134 patients have treated 1,706 attacks with EKTERLY

KONFIDENT-S is an open-label study in which 134 adult and adolescent patients (≥12 years of age) with HAE enrolled. Over the course of the study, attacks were treated with EKTERLY across all severities and attack locations, including 32 laryngeal attacks. The safety profile in KONFIDENT-S was consistent with that seen in the KONFIDENT trial. Treatment-related side effects occurred in 9% of patients, with headache (3.7%) and vomiting (2.2%) being the most commonly reported.

In KONFIDENT-S, laryngeal attacks had a median time
to beginning of symptom relief of 1.3 hours. There
was no reported difficulty swallowing EKTERLY
during laryngeal attacks.

Hand holding EKTERLY® (sebetralstat) tablets Hand holding EKTERLY® (sebetralstat) tablets
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INDICATION AND IMPORTANT SAFETY INFORMATION

WHAT IS EKTERLY® (sebetralstat)?

EKTERLY is a prescription medicine used to treat sudden (acute) attacks of hereditary angioedema (HAE) in adults and children aged 12 years of age and older. It is not known if EKTERLY is safe and effective in children under 12 years of age.

IMPORTANT SAFETY INFORMATION

Before taking EKTERLY, tell your healthcare provider about all of your medical conditions, including if you:

  • Are pregnant or planning to become pregnant. It is not known if EKTERLY can harm your unborn baby.
  • Are breastfeeding or plan to breastfeed. It is not known if EKTERLY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby while taking EKTERLY.
  • Have liver problems.

Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking EKTERLY with certain other medicines can cause side effects or affect how well EKTERLY or the other medicines work. Especially tell your healthcare provider if you take any of the following, as their use with EKTERLY is not recommended: itraconazole, phenytoin, efavirenz.

Know the medicines you take. Keep a list of them to show your healthcare provider or pharmacist when you get a new medicine.

What are the possible side effects of EKTERLY?

The most common side effects of EKTERLY include headache. For more information, ask your healthcare provider or pharmacist. Talk to your doctor for medical advice about side effects.

You are encouraged to report side effects related to KalVista products by calling 1-855-258-4782. If you prefer, you may contact the U.S. Food and Drug Administration (FDA) directly. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Please click here for full Prescribing Information, including Patient Information.