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AstraZeneca's Fasenra Gets FDA Nod for Self-Administration

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AstraZeneca plc (AZN - Free Report) announced that the FDA has approved a self-administration option for its asthma drug, Fasenra (benralizumab) in a new delivery method — a pre-filled, single-use auto-injector called the Fasenra pen.

The FDA approval of the self-administration option and the Fasenra pen is supported by data from the phase III GRECO study and the phase I AMES studies. The safety and tolerability of Fasenra in these studies were consistent with the known profile of the medicine. With the approval, Fasenra becomes the only respiratory biologic that offers a convenient option of administering Fasenra at home or in a doctor’s office in an 8-week maintenance dosing schedule. The self- administration option and the Fasenra pen are also approved in the EU.

Fasenra is currently approved as an add-on maintenance treatment for severe eosinophilic asthma in the United States, Europe, Japan and other countries. GlaxoSmithKline’s (GSK - Free Report) Nucala and Teva Pharmaceutical Industries' (TEVA - Free Report) Cinqair are presently marketed for the same indication. Other drugs approved to treat asthma are Novartis (NVS - Free Report) /Roche’s Xolair and Sanofi/Regeneron’s Dupixent.

Fasenra recorded sales of $296 million in the first half of 2019, representing growth of 249% at a constant exchange rate. According to AstraZeneca, Fasenra enjoys leadership position among novel biologic asthma medicines in the United States and European countries like Germany and Japan.

Until now, Fasenra could be administered at a fixed-dose subcutaneous injection via a prefilled syringe, once in every eight weeks. The approval of the convenient self-administration option in the Fasenra pen should raise demand and bring in higher sales.

Fasenra is also being developed for severe nasal polyposis, other eosinophilic diseases and chronic obstructive pulmonary disease (COPD). However, two phase III studies evaluating Fasenra to treat COPD patients did not result in a statistically-significant reduction of exacerbations in such patients compared to placebo, thereby failing to meet the primary endpoint, per data announced in May last year.

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