New asthma drug! AstraZenega Fasenra Phase 3 Clinical: Eliminate oral corticosteroid (OCS) needs in most patients!

October 31, 2020 // -- AstraZeneca has released high-level results from the open label Phase 3b PONENTE study of the anti-inflammatory drug Fasenra (benralizumab) for asthma.
data show that Fasenra eliminates the use of OCS in most patients with oral corticosteroid (OCS)-dependent asthma, which has a wide range of blood acidophil counts.
asthma is a often debilitating disease that affects about 34 million people worldwide.
more than one-third of these patients are currently using chronic or intermittent OCS on the basis of other therapies to control their symptoms and acute exacerbation.
, frequent or long-term use of OCS can lead to serious adverse effects.
PONENTE is a multi-center, open-label, single-arm, IIIb phase trial conducted to assess the effectiveness and safety of daily OCS use after receiving high-dose inhaled corticosteroids (ICS), long-acting beta-2 astrations (LABA), long-term use of OCS therapy, co-use or non-addition of additional asthma control drugs.
showed that 62% of patients at the first major endpoint completely eliminated daily use of OCS.
In the second major endpoint, 81% of patients achieved complete elimination, or were able to reduce their daily OCS dose to 5 mg or less when further reductions were not possible due to adrenal insemusity.
two major endpoints last at least four weeks while maintaining asthma control.
PONENTE includes nearly 600 patients in Europe, North America, South America and Taiwan.
by reducing the use of high-dose OCS by adopting faster steroid reduction programs in patients without adrenal insanity, the PONENTE trial expanded the data previously found in the ZONDA Phase 3 trial to reduce OCS use.
PONENTE trials also have a longer duration of about 24-32 weeks, and PONENTE trials have shown more lasting OCS reduction and asthma control than ZONDA and all other published biopharmaceasury trials.
PONENTE trials, Fasenra's safety and tolerance were consistent with known drug characteristics.
results will be presented at an upcoming medical conference.
Professor Andrew Menzies Gow, director of lung medicine at the Royal Brompton Hospital in London and lead investigator on the PONENTE trial, said: "These exciting results demonstrate Fasenra's role in eliminating or reducing oral corticosteroids (OCS).
particularly important for the reduction achieved through the personalized OCS reduction program, as adrenal insemuction can be an obstacle to safe and meaningful OCS reduction.
data will provide information on guidelines for the treatment of severe asthma and increase doctors' confidence to more safely eliminate long-term OCS in patients.
"Currently, 13.5 million people with severe asthma worldwide rely on oral corticosteroids (OCS) to control their deterioration and prevent hospitalization," said Mene Pangalos, executive vice president of biopharmaceutical research and development at AstraZenecon.
, over-reliance on OCS can also pose serious health risks and put additional pressure on the health system.
data further support The clinical profile of Fasenra's elimination of OCS in a wider group of people with severe asthma.
"Fasenra's active pharmaceutical ingredient is benralizumab, a monoclonal antibody that binds directly to the α subkey (IL-5R alpha) receptor of leukocytes on acidic granulocytes and uniquely attracts natural killer cells (NK cells) to induce rapid and almost complete depletion of eosinophils through apoptosis (procedural cell death).
, Fasenra has been approved in the United States, the European Union, Japan and other countries and regions as an additional maintenance therapy for the treatment of severe eosinophil asthma.
addition, the Fasenra self-medication option has been approved by the United States and the European Union to be self-administration by patients with a new pre-charged, disposable auto-injector (Fasenra pen).
Fasenra was licensed by AstraZeneta from BioWa, a wholly owned subsidiary of Kyowa Hakko Kirin, a Japanese pharmaceutical company.
the end of March, AstraZeneta signed a new agreement with Concorde Kirin to grant Fasenra full Asian rights.
In addition to approved eosinophilic asthma adaptations, AstraZeneone is evaluating Fasenra's treatment of eight acidophil-driven diseases, including severe nasal polyps, eosinophilitis (EoE), high eosinophil syndrome (HES), eosinophilic granulitis (EGPA), chronic obstructive pulmonary disease (COPD), and more.
, the FDA had granted Fasenra the status of orphan drugs for the treatment of EoE, HES, and EGPA.
() Original origin: Fasenra eliminated oral corticosteroid use in a majority of OCS-dependent patients with asthma in PONENTE Phase IIIb trial