NATRON safety results
Adverse reactions (≥5%) in NATRON*1
| FASENRA N=67; n (%) |
Placebo N=66; n (%) |
|
|---|---|---|
| Headache | 11 (16.4) | 5 (7.6) |
| Upper respiratory tract infection | 5 (7.5) | 5 (7.6) |
| COVID-19 | 4 (6.0) | 4 (6.1) |
| Influenza-like illness | 4 (6.0) | 0 |
| Arthralgia | 3 (4.5) | 5 (7.6) |
| Nasopharyngitis | 3 (4.5) | 4 (6.1) |
The most common adverse reactions (≥5% and more common than placebo) with FASENRA in NATRON were headache in 11 patients (16%), hypersensitivity reactions (including urticaria, urticaria papular, rash) in 6 patients (9%), and influenza-like illness in 4 patients (6%).2
Pivotal asthma studies safety profile
Adverse reactions for FASENRA in asthma pivotal studies2
| ADVERSE REACTIONS (≥3%) (SIROCCO AND CALIMA) |
||
|---|---|---|
| FASENRA (n=822) | Placebo (n=847) | |
| Headache | 8% | 6% |
| Pyrexia | 3% | 2% |
| Pharyngitis† | 5% | 3% |
| Hypersensitivity reactions‡ | 3% | 3% |
Injection Site Reactions
In pivotal asthma studies, injection site reactions with FASENRA were similar to placebo: 2.2% vs 1.9%, respectively.§2
Following approval for asthma, FASENRA has been prescribed to more than 150,000 patients with asthma in the US∥3
*Adverse reactions were classified with the use of Medical Dictionary for Regulatory Activities, version 28.0, preferred terms. The total duration of exposure during the double-blind period was 30.6 patient-years in the FASENRA group and 29.9 patient-years in the placebo group.1
†Pharyngitis was defined as follows: pharyngitis, pharyngitis bacterial, viral pharyngitis, and pharyngitis streptococcal.2
‡Hypersensitivity reactions were defined as follows: urticaria, urticaria papular, and rash.2
§Severe Asthma Trial 1: 48-week exacerbation reduction trial; Severe Asthma Trial 2: 56-week exacerbation reduction trial.2
∥Based on US data from specialty pharmacies and distributors from December 2017 to November 2025 for new patients starting FASENRA.3
