AZ's bid for Fasenra approval in COPD falls short
AstraZeneca's hopes of a big new indication for respiratory drug Fasenra in chronic obstructive pulmonary disease (COPD) have been dashed by a negative phase 3 trial.
The RESOLUTE study of IL-5 inhibitor Fasenra (benralizumab) showed some improvement with Fasenra compared to placebo in reducing COPD exacerbations, or attacks, that signal progression of the debilitating and irreversible disease. However, the difference was not statistically significant and AZ has said it will now focus on other candidates in its pipeline for COPD.
The disappointing result means that AZ will be unable to follow in the footsteps of GSK, whose IL-5 inhibitor Nucala (mepolizumab) was approved for COPD earlier this year, as well as Sanofi/Regeneron's IL-4 and IL-13 inhibitor Dupixent (dupilumab), which became the first biologic to get the go-ahead in COPD treatment in 2024.
The RESOLUTE failure marks the end of a long road for AZ in trying to bring Fasenra to regulatory approval in COPD, coming after earlier negative trials, including the phase 3 GALATHEA and TERRANOVA studies in 2018.
First launched in 2017, Fasenra is already approved as an add-on maintenance treatment for severe eosinophilic asthma and for eosinophilic granulomatosis with polyangiitis (EGPA), with regulatory reviews underway to extend its label to include hypereosinophilic syndrome (HES).
It is AZ's second biggest-selling respiratory product, with sales of $920 million in the first half of this year, but there is no doubt that it will miss out on a considerable market opportunity after losing its shot at a COPD indication.
COPD is the third leading cause of death worldwide, affecting more than 300 million people globally. Up to 40% of patients exhibit type 2 inflammation, characterised by a raised blood eosinophil count, which would make them suitable for treatment with biologics like Fasenra.
Market research firm GlobalData predicted earlier this year that sales of COPD therapies in seven top pharma markets will grow from $11.6 billion in 2023 to more than $30 billion in 2033, driven by uptake of Dupixent and Nucala.
Lupus win
There was better news for AZ this week with the readout of the phase 3 trial of a new subcutaneous formulation of Saphnelo (anifrolumab), the company's first-in-class type I interferon receptor antagonist, in patients with systemic lupus erythematosus (SLE).
An intravenous formulation of Saphnelo has been on the market since 2022, after it was approved as an add-on therapy to standard treatment for adults with moderate to severe SLE, and has been growing well, with sales up 49% to just over $300 million in the first half of this year.
In the TULIP-SC trial, a once-weekly injection with Saphnelo demonstrated a statistically significant and clinically meaningful reduction in disease activity compared to placebo and, according to AZ, was consistent with the current IV version, which is given every four weeks.
"The TULIP-SC results are especially important because approximately half of [SLE] patients today taking a biologic are already treated with a self-administered subcutaneous option," said Sharon Barr, AZ's head of biopharma R&D.
"With Saphnelo, we hope to establish remission as an achievable treatment goal for more patients, and we are actively working with regulatory authorities to bring this new administration option to patients as soon as possible," she added.
Saphnelo is the first biologic drug for SLE not restricted to patients with a high degree of disease activity, and can be used in a broader patient population than GSK's BLyS inhibitor Benlysta (belimumab), which is dosed subcutaneously once a week with an autoinjector.
