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AZ prices severe asthma drug Fasenra below competition

The discounted drug will cost $38,000 in the first year


The US FDA has approved AstraZeneca’s interleukin-5 inhibitor Fasenra for severe asthma, setting up a fight in the market with rival drugs from GlaxoSmithKline and Teva.

It’s the first approval for Fasenra (benralizumab), as well as the first for AZ’s emerging portfolio of respiratory biologic drugs, and the company says it is taking the marketing battle to its competitors by pricing the drug at a discount to GSK’s Nucala (mepolizumab) and Teva’s Cinqair/Cinqaero (reslizumab) - also IL-5 inhibitors.

Fasenra will be priced at $38,000 in the first year, dropping to $28,000-$33,000 in subsequent years as a maintenance therapy, which it maintains is a discount to all other biologics used in severe asthma, according to Reuters.

AZ is also emphasising the drug’s maintenance dosing frequency of every eight weeks, whereas Nucala and Cinqair require monthly doses. Like Nucala it is administered by subcutaneous injections while Cinqaero requires an intravenous infusion. The drug is also on the brink of EU approval having picked up a CHMP positive opinion late last week.

The FDA approval is based on the SIROCCO, CALIMA and ZONDA, trials  which showed that benralizumab could curb asthma exacerbations by up to 51% and improved lung function (as measured by forced expiratory volume) within four weeks of starting treatment. In the trials, 75% of patients on the drug reduced their use of oral corticosteroids - which are linked to potentially serious side effects if used chronically - and 52% were able to do away with them altogether.

The US regulator has approved the drug as an add-on treatment for severe eosinophilic asthma in patients over 12. The eosinophilic form is seen in about half of all severe asthma patients and is associated with worse symptoms, decreased lung function and a higher risk of breakthrough asthma attacks.

“Fasenra is the only respiratory biologic that provides direct, rapid and near-complete depletion of eosinophils within 24 hours,” said AZ in a statement.

Along with Nucala and Cinqair, severe asthma patients can also be treated with Novartis’ older drug Xolair (omalizumab), although that is indicated for allergic asthma and doesn’t specifically address eosinophilic inflammation.

Fasenra is one of a trio of respiratory biologics that AZ has developed to try to re-inject some growth in its respiratory franchise, which has been hit by patent expirations and pricing pressure. Prospects for IL-13 inhibitor tralokinumab look rocky after two failed late-stage trials, elevating the importance of Fasenra in those plans.

AZ also has an Amgen-partnered thymic stromal lymphopoietin (TSLP) targeting antibody - tezepelumab - in phase III testing for severe asthma after reporting strong phase II data in uncontrolled patients earlier this year.

Article by
Phil Taylor

15th November 2017

From: Sales



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