FDA declines approval for AstraZeneca’s chronic rhinosinusitis antibody
The US Food and Drug Administration (FDA) has declined to grant approval to AstraZeneca’s Fasenra (benralizumab) to treat individuals with inadequately controlled chronic rhinosinusitis with nasal polyps (CRSwNP).
In-licensed from BioWa, a Kyowa Kirin subsidiary by AstraZeneca, Fasenra is a monoclonal antibody.
It attaches to IL-5 receptor alpha on eosinophils and triggers natural killer cells to elicit quick and near-complete blood and tissue eosinophil depletion through apoptosis in most patients.
On average, it takes a pharmaceutical company at least ten years to bring a new medicine through the complete drug development process. This long journey involves five key stages, moving from initial discovery and development to preclinical and clinical research. These are followed by regulatory review – typically the most complex and difficult portion of the process, whereby a New Drug Application (NDA) is filed – and FDA post-market safety monitoring.
The manufacturer’s work doesn’t stop there, however. Now, they must find ways to maximise the value of the product across its roughly 20-year lifecycle...
A complete response letter (CRL) was issued by the regulatory agency to the company in response to the supplemental Biologics License Application (sBLA) for Fasenra to treat CRSwNP.
The sBLA application comprised results from the double-blinded, randomised, parallel-group, multicentre Phase III OSTRO clinical trial that analysed the safety and efficacy of subcutaneous dose of Fasenra versus placebo in nasal polyposis patients.
Findings showed that the trial met both co-primary endpoints and Fasenra demonstrated to possess a safety profile in line with its already reported data.
In the CRL, the FDA sought further clinical data and AstraZeneca is working with the regulatory authority on further actions.
At present, a randomised, double-blinded, multi-centre, parallel-group Phase III ORCHID trial is underway analysing the safety and efficacy of Fasenra compared to placebo in eosinophilic CRSwNP patients.
The results from this trial are anticipated in the second half of next year.
The antibody therapy is also approved for self-administration in the EU, the US and other nations.
In 2019, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) provided a positive recommendation for AstraZeneca’s Fasenra Pen, a pre-filled, single-use auto-injector.
March 15, 2022
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