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AMGEN

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AstraZeneca gets FDA breakthrough therapy label for asthma treatment

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09/07/2018 | 02:46am EST
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 0.89% 188.34 Delayed Quote.-3.25%
ASTRAZENECA -1.36% 6156 Delayed Quote.4.82%
GLAXOSMITHKLINE -0.63% 1571 Delayed Quote.5.35%
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Financials ($)
Sales 2019 22 796 M
EBIT 2019 11 016 M
Net income 2019 7 710 M
Finance 2019 4 441 M
Yield 2019 3,01%
P/E ratio 2019 15,36
P/E ratio 2020 13,99
EV / Sales 2019 4,95x
EV / Sales 2020 4,47x
Capitalization 117 B
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Number of Analysts 23
Average target price 204 $
Spread / Average Target 8,5%
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Managers
NameTitle
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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