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Amgen (AMGN)/AstraZeneca's Asthma Drug Gets FDA Priority Tag

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Amgen Inc. (AMGN - Free Report) , along with its partner AstraZeneca PLC (AZN - Free Report) , announced that the FDA has accepted the biologics license application (“BLA”) for their promising monoclonal antibody, tezepelumab, which has been developed for the treatment of asthma.

With the FDA granting a priority review to the BLA, a decision from the regulatory body is expected in the first quarter of 2022.

The BLA for tezepelumab was based on data from the PATHFINDER clinical program, which includes the pivotal phase III NAVIGATOR study which evaluated tezepelumab for treating patients with severe, uncontrolled asthma.

Data from the NAVIGATOR study showed that treatment with tezepelumab demonstrated superiority across all the primary and key secondary endpoints versus placebo for treating uncontrolled asthma in patients who received treatment with medium- or high-dose inhaled corticosteroids, and at least one additional controller medication with or without oral corticosteroids.

Per the company, tezepelumab is the first and only biologic treatment which has consistently and significantly reduced asthma exacerbations in patients across mid- to late-stage studies.

Shares of Amgen have rallied 5.8% so far this year against the industry’s decline of 1.1%.

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We remind investors, that last November, tezepelumab met the primary endpoint in the phase III NAVIGATOR study which evaluated the candidate for treating patients with severe, uncontrolled asthma.

The FDA granted Breakthrough Therapy designation to tezepelumab for the treatment of patients with severe, uncontrolled asthma without an eosinophilic phenotype in September 2018.

Competitive pressure in the overall asthma market has intensified over the years. Upon potential approval, tezepelumab is likely to face stiff competition from GlaxoSmithKline’s (GSK - Free Report) Nucala and Regeneron (REGN - Free Report) /Sanofi’s blockbuster medicine Dupixent, which are approved for treating patients with severe asthma and some other indications as well.

Zacks Rank

Amgen currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

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