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AstraZeneca’s Asthma Drug Gets Breakthrough Therapy Status


AstraZeneca AZN and partner Amgen AMGN announced that the FDA granted Breakthrough Therapy designation to their asthma candidate, tezepelumab. Tezepelumab is an anti-thymic stromal lymphopoietin monoclonal antibody being evaluated for the treatment of patients with severe, uncontrolled asthma without an eosinophilic phenotype.

The Breakthrough Therapy designation from the FDA is expected to speed up the development and review of drugs intended to treat serious or life-threatening diseases. AstraZeneca believes that tezepelumab has the potential to treat a broad population of severe asthma patients including those who cannot be treated with presently marketed biologic therapies.

Shares of AstraZeneca have increased 6.8% year to date compared with the industry’s growth of 4.2%.

The Breakthrough Therapy designation was supported by the data from the tezepelumab phase IIb PATHWAY study. The data showed that tezepelumab reduced the annual asthma exacerbation rate (“AAER”), a measure of deterioration of asthma,compared with placeboin patients with severe, uncontrolled asthma.

The PATHWAY study compared three doses of the candidate — 70 mg or 210 mg every four weeks or 280 mg every two weeks — to a placebo. Tezepelumab was administered as an add-on therapy in patients who have experienced asthma exacerbations and uncontrolled asthma, despite treatment with asthma controllers like corticosteroids. The candidate showed a reduction in AAER of 62%, 71% and 66% for 70 mg, 210 mg and 280 mg doses, respectively.

Tezepelumab is currently in development stage in the phase III PATHFINDER program, which includes two pivotal studies — NAVIGATOR and SOURCE.

Earlier this week, Pfizer, Inc. PFE received the FDA’s Breakthrough Therapy designation for its pipeline candidate, PF-06651600. The candidate is being developed for alopecia areata, a chronic autoimmune skin disease that causes hair loss on the scalp, face, or body.

AstraZeneca PLC Price

Zacks Rank & A Stock to Consider

AstraZeneca is a Zacks Rank #3 (Hold) stock.

A better-ranked stock in the same space is Eli Lilly and Company LLY, carrying a Zacks Rank #2 (Buy).You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Lilly’s earnings per share estimates have increased from $5.15 to $5.47 for 2018 and from $5.48 to $5.73 for 2019 over the past 60 days. The company delivered a positive earnings surprise in all of the trailing four quarters with an average beat of 10.15%. The stock has rallied 24.8% so far this year.

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