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AZ gets EMA green light for severe asthma drug Fasenra

The biologic respiratory treatment will go up against GSK’s Nucala and Teva’s Cinqaero

AZ

AstraZeneca has picked up an approval in the EU for its interleukin-5 inhibitor Fasenra in severe asthma, mirroring its US approval in this indication last November.

Fasenra (benralizumab) is the third IL-5-targetting drug approved for market after GlaxoSmithKline’s Nucala (mepolizumab) and Teva’s Cinqaero (reslizumab) and according to AZ, it is the first biologic respiratory drug with an eight-week dosing schedule.

The new drug has been given a green light by the EMA as an add-on maintenance treatment for severe eosinophilic asthma in patients who can’t control symptoms using high-dose inhaled corticosteroids plus long-acting beta agonist drugs.

Fasenra is AZ’s first biologic respiratory drug, and is setting off in pursuit of Nucala, which brought in sales of £223m (around $300m) in the first nine months of 2017, as well as Cinqaero which had yet to make sufficient sales to warrant a sales breakdown in Teva’s third-quarter results perhaps held back by its intravenous administration while Nucala is delivered subcutaneously.

AZ’s drug is also given via subcutaneous injection, and its longer dosing interval (eight weeks versus four weeks after a lead-in period) could make it a stronger challenger to GSK despite arriving to market well behind the leader, which has also picked up an additional approval in chronic obstructive pulmonary disease (COPD) and is in late-stage trials for other indications, including nasal polyposis as well.

To help matters along AZ is offering Fasenra at a discount to Nucala in the US, although it hasn’t yet revealed its pricing plans in Europe, and has said it intends to put a lot of marketing muscle behind both the US and EU launches. It also has a follow-up trial in COPD in play.

Fasenra is currently under regulatory review in Japan and several other countries, with verdicts decisions in the first half of this year, said the company.

“Many patients with severe eosinophilic asthma experience debilitating symptoms and face increased risk of emergency room visits, hospitalisations and death, despite current treatments,” said asthma specialist Tim Harrison of Nottingham University, one of the Fasenra clinical investigators.

“I look forward to being able to offer Fasenra as a new anti-eosinophilic monoclonal antibody which has demonstrated efficacy versus placebo in pivotal clinical trials and has the convenience of an eight-week maintenance dosing regimen.”

Fasenra is one of three of respiratory biologics that AZ has developed to try to restore growth in its respiratory franchise, which has been hit by patent expirations and pricing pressure. Prospects for IL-13 inhibitor tralokinumab look terminal after three failed late-stage trials, however, and AZ also has an Amgen-partnered thymic stromal lymphopoietin (TSLP) targeting antibody - tezepelumab - in phase III testing for severe asthma.

Article by
Phil Taylor

11th January 2018

From: Regulatory

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