AstraZeneca’s FASENRA shows positive results in rare disease trial

Published 07/11/2025, 15:06
AstraZeneca’s FASENRA shows positive results in rare disease trial

WILMINGTON - AstraZeneca’s FASENRA (benralizumab) demonstrated significant benefits for patients with hypereosinophilic syndrome (HES) in a Phase III trial, according to data presented at the American College of Allergy, Asthma and Immunology Annual Scientific Meeting in Orlando. The $262.5 billion pharmaceutical giant, recognized as a prominent player in the industry according to InvestingPro data, continues to expand its treatment portfolio with strong clinical results.

The NATRON trial showed that FASENRA reduced the risk of disease worsening or flare by 65% compared to placebo. Patients receiving the treatment experienced a 30 mg subcutaneous injection once every four weeks.

HES is a rare disorder characterized by elevated levels of eosinophils in the blood that can lead to organ damage and may be fatal if left untreated.

The study met its primary endpoint with FASENRA delaying the time to first HES worsening or flare. Secondary endpoints were also achieved, including a 66% reduction in the annualized rate of HES flares compared to placebo and delayed time to first hematologic relapse.

Patients treated with FASENRA showed greater improvement in fatigue symptoms by week 4, which persisted through week 24 of the trial.

"The NATRON results suggest we have the potential to help HES patients with benralizumab, significantly reduce the risk of flares, hematologic relapse and improve fatigue severity compared to placebo with a single monthly dose regime," said Princess U. Ogbogu, the trial’s principal investigator.

The safety profile observed in the trial was consistent with FASENRA’s known profile from previous studies.

FASENRA is currently approved in over 80 countries for severe eosinophilic asthma and in more than 60 countries for eosinophilic granulomatosis with polyangiitis.

The information in this article is based on a press release statement from AstraZeneca.

In other recent news, AstraZeneca has received European Commission approval for Koselugo to treat symptomatic, inoperable plexiform neurofibromas in adults with neurofibromatosis type 1. This decision follows the positive results of the KOMET Phase III trial, which demonstrated a 20% objective response rate in reducing tumor size. Additionally, AstraZeneca received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) for the subcutaneous administration of Saphnelo in the EU for systemic lupus erythematosus patients. Jefferies has upgraded AstraZeneca’s stock rating to Buy, citing an undervalued oncology portfolio, and has increased its price target. Conversely, Deutsche Bank downgraded AstraZeneca to Sell, expressing concerns about the company’s pipeline, particularly in breast cancer treatments. In corporate governance developments, AstraZeneca’s non-executive director, Euan Ashley, has joined the board of DexCom, Inc. These updates reflect AstraZeneca’s ongoing activities in drug development and market positioning.

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