AstraZeneca earns FDA nod for at-home autoinjector

By Vassia Barba contact

- Last updated on GMT

(Image: Getty/Who_I_am)
(Image: Getty/Who_I_am)

Related tags: Astrazeneca, Fda, Gsk, Glaxosmithkline

US FDA approves AstraZeneca’s at-home autoinjector for administration of an add-on treatment for severe asthma, matching the indication of GSK’s rival product, Nucala.

AstraZeneca announced the US Food and Drug Administration (FDA) approval of Fasenra (benralizumab) in a pre-filled, single-use autoinjector, known as Fasenra Pen, which enables self-administration at home.

The drug, which was initially approved by the FDA in 2017​, is an add-on maintenance treatment of patients with severe asthma aged 12 years and older, which binds to the IL-5α receptor on an eosinophil and uniquely attracts natural killer cells to induce apoptosis.

The newly-approved pen rivals Nucala (mepolizumab) autoinjector, marketed by GlaxoSmithKline, which was approved earlier this year​.

Fasenra is also available as a subcutaneous injection via a prefilled syringe. However, the product in syringe requires administration by a healthcare professional in a clinical setting, unlike Nucala safety syringe, which is available for at-home administration by patients or their caregivers after ‘appropriate training’, according to GSK.

Treatment with Fasenra Pen includes dosing every four weeks for the first three doses and once every eight weeks thereafter, while Nucala requires repeated dosing every four weeks.

In September 2018, GSK failed to get Nucala on the US market as a treatment for chronic obstructive pulmonary disease, with the FDA rejecting​ the drugmaker’s application. 

Fasenra, which is the first respiratory biologic developed by AstraZeneca, is currently also being evaluated for the treatment of COPD, as well as for severe nasal polyposis and other eosinophilic diseases.

The FDA has also granted orphan drug designation to Fasenra for the treatment of eosinophilic granulomatosis with polyangiitis in November 2018, hypereosinophilic syndrome in February 2019, and eosinophilic oesophagitis in August 2019.

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