CHMP Endorses AstraZeneca's Fasenra in Rare Autoimmune Disease
AstraZeneca AZN announced that the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended approving the regulatory filing seeking label expansion in the EU for its blockbuster asthma drug Fasenra (benralizumab) in eosinophilic granulomatosis with polyangiitis (EGPA) indication.
EGPA is a rare autoimmune disease that can cause damage to multiple organs and tissues. The AZN filing seeks marketing authorization for Fasenra as an add-on treatment for adult patients with relapsing or refractory EGPA.
This recommendation is based on data from the phase III MANDARA study, which compared a single monthly injection of Fasenra to three injections per month of GSK’s GSK blockbuster drug, Nucala (mepolizumab). This is also the first approved targeted therapy for EGPA. Data from this study showed that nearly 60% of patients treated with Fasenra achieved remission, which was comparable to GSK’s Nucala-treated patients. Around 41% of patients treated with Fasenra entirely stopped taking oral corticosteroids compared to 26% in the Nucala arm.
Last week, the FDA approved Fasenra in EGPA indication, also supported by data from the MANDARA study. The drug is already approved as an add-on maintenance treatment for severe eosinophilic asthma (SEA) in the United States and Europe.
If approved, Fasenra will be the second biologic approved in the European Union to treat EGPA. A potential approval for the drug is also likely to benefit EGPA patients since there are limited treatment options. Per management, nearly half of EGPA patients fail to reach remission with current treatments. The AZN drug offers a more convenient option to patients — Fasenra requires a single monthly subcutaneous injection compared with three injections per month in the case of GSK’s Nucala.
AZN Stock Performance
Year to date, AstraZeneca’s shares have moved up 14.5% compared with the industry’s 23.5% rise.
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Fasenra – A Key Top-line Driver for AZN
Fasenra is currently approved in more than 80 countries across the world, including the United States, European Union and Japan for SEA. The drug added sales worth $781 million to AstraZeneca’s top line in the first half of 2024, up 6% year over year. Sales of the drug have been rising, driven by strong demand growth and market share.
AstraZeneca is evaluating the drug in several label expansion studies for eosinophil-driven diseases, including chronic obstructive pulmonary disease (COPD), chronic rhinosinusitis with nasal polyps (CRSwNP) and hypereosinophilic syndrome (HES). Continued label expansion for Fasenra into additional indications and patient populations should boost drug sales in the days ahead.
Another Clinical Setback for Daiichi-Partnered Drug This Month
In a separate press release, AstraZeneca reported results from the late-stage TROPION-Breast01 study, which evaluated its investigational antibody drug conjugate, datopotamab deruxtecan (Dato-DXd), in patients with a certain type of breast cancer. The drug is being developed in partnership with Japan-based Daiichi Sankyo.
The study did not achieve statistical significance in the final overall survival (OS) analysis, one of the dual primary endpoints of the study. The study had previously met the other dual primary endpoint of progression-free survival (PFS).
Management intends to share results from this study with regulatory authorities to determine its next steps for the clinical program evaluating Dato-DXd in breast cancer indication.
This is the second clinical setback for Dato-DXd this month. Earlier, AZN reported detailed results from the phase III TROPION-Lung01 study on the drug in certain patients with non-small cell lung cancer (NSCLC). Data from this study also showed that the treatment with the drug did not achieve statistical significance in OS, one of the study’s dual primary endpoints. This study had previously achieved the other primary endpoint of PFS.
AZN’s Zacks Rank
AstraZeneca currently carries a Zacks Rank #3 (Hold).
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