WILMINGTON, Del.--(BUSINESS WIRE)--AstraZeneca today announced that the US Food and Drug Administration (FDA) has approved the self-administration of FASENRA® (benralizumab) in a pre-filled, single-use auto-injector (the FASENRA Pen™).
The approval is supported by data from the Phase III GRECO trial and the Phase I AMES trial, which achieved their primary objective of usability and pharmacokinetic (PK) exposure, respectively. The safety and tolerability of FASENRA in these trials were consistent with the established profile of the medicine.
Mene Pangalos, Executive Vice President, BioPharmaceuticals R&D, said: “FASENRA is the only respiratory biologic that can be given every eight weeks after the initial loading-dose period. Today’s news means we can now offer FASENRA in an even more convenient way, giving US healthcare providers and patients the option of administering FASENRA at home or in a doctor’s office, and making treatment more accessible to patients with severe eosinophilic asthma.”
Reynold Panettieri, MD, Vice Chancellor for Translational Medicine and Science and Director of Rutgers Institute for Translational Medicine and Science, said: “As a clinician, I use FASENRA in my office because of its efficacy and safety data. The importance of this approval is that my patients and I now have another option to personalize their treatment approach to help meet their needs and fit their lifestyle.”
FASENRA self-administration and the FASENRA Pen are also approved in the European Union (EU). FASENRA is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the US, EU, Japan and other countries.
FASENRA is not approved for the treatment of other eosinophilic conditions or relief of acute bronchospasm or status asthmaticus.
IMPORTANT SAFETY INFORMATION
Known hypersensitivity to benralizumab or excipients.
WARNINGS AND PRECAUTIONS
Hypersensitivity reactions (eg, anaphylaxis, angioedema, urticaria, rash) have occurred after administration of FASENRA. These reactions generally occur within hours of administration, but in some instances have a delayed onset (ie, days). Discontinue in the event of a hypersensitivity reaction.
Acute Asthma Symptoms or Deteriorating Disease
FASENRA should not be used to treat acute asthma symptoms, acute exacerbations, or acute bronchospasm.
Reduction of Corticosteroid Dosage
Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with FASENRA. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the direct supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
Parasitic (Helminth) Infection
It is unknown if FASENRA will influence a patient’s response against helminth infections. Treat patients with pre-existing helminth infections before initiating therapy with FASENRA. If patients become infected while receiving FASENRA and do not respond to anti-helminth treatment, discontinue FASENRA until infection resolves.
The most common adverse reactions (incidence ≥ 5%) include headache and pharyngitis.
Injection site reactions (eg, pain, erythema, pruritus, papule) occurred at a rate of 2.2% in patients treated with FASENRA compared with 1.9% in patients treated with placebo.
USE IN SPECIFIC POPULATIONS
A pregnancy exposure registry monitors pregnancy outcomes in women exposed to FASENRA during pregnancy. To enroll call 1-877-311-8972 or visit www.mothertobaby.org/fasenra.
The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies such as benralizumab are transported across the placenta during the third trimester of pregnancy; therefore, potential effects on a fetus are likely to be greater during the third trimester of pregnancy.
FASENRA is indicated for the add-on maintenance treatment of patients with severe asthma aged 12 years and older, and with an eosinophilic phenotype.
- FASENRA is not indicated for treatment of other eosinophilic conditions
- FASENRA is not indicated for the relief of acute bronchospasm or status asthmaticus
About GRECO and AMES
GRECO is a Phase III multicenter, open‑label, 28-week trial designed to assess patient‑ or caregiver‑reported functionality, performance and reliability of a pre-filled auto-injector device with a fixed 30 mg dose of FASENRA administered subcutaneously (SC) every four weeks in clinic and in an at‑home setting in 120 adults with severe, uncontrolled asthma. The majority (97%) of at-home administrations by patients or caregivers were successful at week 12 and week 16 and nearly all (96%) of the returned pre-filled auto-injector devices used to administer FASENRA at home were evaluated as being functional at week 12 and week 16.
AMES is a multicenter, randomized, open-label, parallel group Phase I trial in healthy people to compare the pharmacokinetic (PK) exposure following single 30 mg SC administration of FASENRA by using pre-filled syringe or pre-filled auto-injector devices. FASENRA PK exposure was comparable following SC administration via a pre-filled syringe or a pre-filled auto-injector. Eosinophils were rapidly depleted in patients from both device groups.
The safety profile in both trials was similar to previous trials, with no new or unexpected safety findings. The most common adverse events observed in each trial were:
- GRECO: viral upper respiratory tract infection, asthma, upper respiratory tract infection, headache
- AMES: nasopharyngitis, headache, oropharyngeal pain
About the FASENRA Pen
The US approval of the FASENRA Pen provides healthcare professionals and patients the option for FASENRA to be administered outside of a clinical setting via auto-injector by a patient or caregiver after their healthcare provider determines it is appropriate. The FASENRA pre-filled syringe is available for administration by a healthcare professional.
The FASENRA Pen enables patients and caregivers to administer the medicine via a two-step process. The device includes a viewing window and audible clicks at the start and end of the injection to guide patients with successful administration.
FASENRA® (benralizumab) is a monoclonal antibody that binds directly to the IL-5 receptor alpha on eosinophils and attracts natural killer cells to induce rapid and near-complete depletion of eosinophils via apoptosis (programmed cell death).
FASENRA is AstraZeneca’s first respiratory biologic, approved as an add-on maintenance treatment in severe eosinophilic asthma in the US, EU, Japan and other countries, with further regulatory reviews ongoing. Where approved for self-administration, FASENRA will be available both as a fixed-dose 30 mg SC via a pre-filled, single-use syringe or as the FASENRA Pen, both with a 29-gauge needle, administered once every four weeks for the first three doses and once every eight weeks thereafter.
FASENRA was developed by AstraZeneca and is in-licensed from BioWa, Inc., a wholly owned subsidiary of Kyowa Kirin Co., Ltd., Japan.
About AstraZeneca in respiratory diseases
Respiratory is one of AstraZeneca’s three therapy areas, and our medicines reached more than 18 million patients as maintenance therapy in 2018. AstraZeneca’s aim is to transform asthma and COPD treatment through inhaled combinations at the core of care, biologics for the unmet needs of specific patient populations, and scientific advancements in disease modification.
The Company is building on a 40-year heritage in respiratory disease and AstraZeneca’s capability in inhalation technology spans pressurized metered-dose inhalers and dry powder inhalers, as well as the AEROSPHERE™ Delivery Technology. The company also has a growing portfolio of respiratory biologics including FASENRA (anti-eosinophil, anti-IL-5 receptor alpha), and tezepelumab (anti-TSLP) which has been granted Breakthrough Therapy Designation by the FDA in patients with severe asthma and is in Phase III trials. AstraZeneca’s research aims at addressing underlying disease drivers by focusing on the lung epithelium, lung immunity, lung regeneration and neuronal functions.
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialization of prescription medicines, primarily for the treatment of diseases in three therapy areas - Oncology, Cardiovascular, Renal & Metabolism, and Respiratory. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information, please visit www.astrazeneca-us.com and follow us on Twitter @AstraZenecaUS.