FDA Approves FASENRA® Pre-Filled Auto-Injector Pen for Self-Administration

The Asthma and Allergy Foundation of America (AAFA) is sharing this press release from AstraZeneca to bring you the latest research news quickly.


PRESS RELEASE

FASENRA® (benralizumab) Approved in the US for Self-administration in a New Pre-filled Auto-injector, the FASENRA Pen™

FASENRA is now the only respiratory biologic that offers the choice of administration at home or in a doctor’s office with eight-week maintenance dosing

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.

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.

About FASENRA
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.

About AstraZeneca
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.

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