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AstraZeneca gets FDA breakthrough therapy label for asthma treatment

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09/07/2018 | 08:46am CET
FILE PHOTO: The logo of AstraZeneca is seen on medication packages in a pharmacy in London

(Reuters) - AstraZeneca Plc and Amgen Inc said on Friday the U.S. Food and Drug Administration had granted a breakthrough therapy label for their drug to treat a type of severe asthma, potentially speeding up its development and regulatory review.

The drug, tezepelumab, is an injectable treatment that is expected to help a wider range of patients than existing asthma medicines like GlaxoSmithKline Nucala.

A breakthrough therapy status is designed to expedite the development and regulatory review of medicines that are intended to treat a serious condition and that have shown encouraging early clinical results.

A mid-stage trial in 2017 of 584 patients showed that tezepelumab reduced the annual rate of serious asthma attacks, known as exacerbations, by between 61 percent and 71 percent, depending on dose.

Tezepelumab is currently in late-stage trials.

The drug has shown promise in treating "a broad population of patients with severe asthma, including those ineligible for currently approved biologic therapies," said David Reese, executive vice president of Research and Development at U.S.-based Amgen.

(Reporting by Nivedita Balu in Bengaluru; Editing by Sai Sachin Ravikumar)

Stocks mentioned in the article
ChangeLast1st jan.
AMGEN 0.73% 193.7321 Delayed Quote.9.47%
ASTRAZENECA -1.79% 6204 Delayed Quote.23.35%
GLAXOSMITHKLINE -0.04% 1562 Delayed Quote.18.16%
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Financials ($)
Sales 2018 23 363 M
EBIT 2018 11 785 M
Net income 2018 8 565 M
Finance 2018 2 166 M
Yield 2018 2,71%
P/E ratio 2018 15,21
P/E ratio 2019 14,58
EV / Sales 2018 5,16x
EV / Sales 2019 5,03x
Capitalization 123 B
Duration : Period :
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Mean consensus OUTPERFORM
Number of Analysts 24
Average target price 204 $
Spread / Average Target 6,1%
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Robert A. Bradway Chairman & Chief Executive Officer
Esteban Santos Executive Vice President-Operations
David W. Meline CFO, Chief Accounting Officer & Executive VP
David M. Reese Executive Vice President-Research & Development
Frank C. Herringer Independent Director
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