EKTERLY (sebetralstat)

Following a single oral dose of 600 mg sebetralstat in subjects with HAE, the geometric mean (CV%) C max is 6,080 ng/mL (40%) and AUC 0-inf is 17,600 ng

• h/mL (36%). Following administration of a second oral dose of 600 mg sebetralstat 3 hours after the first dose, C max increases 10% and AUC 0-inf increases 90% when compared to those observed following a single dose. No clinically relevant differences in sebetralstat pharmacokinetics were observed between healthy subjects and patients with HAE. ...

The efficacy of EKTERLY for the treatment of acute attacks of hereditary angioedema (HAE) in adult and pediatric patients aged 12 years and older was evaluated in a double-blind, randomized, placebo-controlled, multicenter crossover clinical trial (KONFIDENT [ NCT05259917 ]). KONFIDENT employed a 3-way, complete crossover design comparing EKTERLY 600 mg and EKTERLY 300 mg to placebo. If needed (as determined by the patient) a second dose could be administered after 3 hours. Patients were required to treat an eligible HAE attack prior to crossover to the next treatment period. Severe laryngeal ...

The most common adverse reaction (incidence ≥2%) is headache. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact KalVista Pharmaceuticals, Inc. at 1-855-258-4782 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in...

None. None ( 4 )

7 DRUG INTERACTIONS Strong and Moderate CYP3A4 Inhibitors : Avoid use with strong CYP3A4 inhibitors. In patients taking moderate CYP3A4 inhibitors, take one dose of 300 mg. A second dose of 300 mg may be taken at least 3 hours after the first dose if response is inadequate, or if symptoms worsen or recur. ( 2.2 , 7.1 , 12.3 ) CYP3A4 Inducers : Avoid use with moderate or strong CYP3A4 inducers. ( 2...