• Disclosure
  • Privacy Policy
  • DMCA Policy
  • CCPA
  • Medical Disclaimer
Thursday, February 2, 2023
Galveston County News Online
  • Home
  • News
  • Business
  • Technology
    • Crytpocurrency
    • Gaming
    • Gadgets
  • Sports
  • Health
  • General
    • Business Services
  • Travel
  • Press Releases
  • Popular
No Result
View All Result
  • Home
  • News
  • Business
  • Technology
    • Crytpocurrency
    • Gaming
    • Gadgets
  • Sports
  • Health
  • General
    • Business Services
  • Travel
  • Press Releases
  • Popular
No Result
View All Result
No Result
View All Result
Home News

U.S. FDA Declines To Approve AstraZeneca Treatment For Chronic Nasal Condition – Reuters.com

us-fda-declines-to-approve-astrazeneca-treatment-for-chronic-nasal-condition-–-reuters.com
Share on FacebookShare on Twitter

The logo of AstraZeneca is seen on a medication package in a pharmacy in London April 28, 2014. REUTERS/Stefan Wermuth

Register now for FREE unlimited access to Reuters.com

March 14 (Reuters) – AstraZeneca Plc (AZN.L) said on Monday the U.S. drug regulator declined to approve its asthma medicine, Fasenra, for treatment of chronic rhinosinusitis with nasal polyps, a condition characterised by benign growths that cause pain and stuffiness.

The London-listed drugmaker said the U.S. Food and Drug Administration (FDA) had issued a complete response letter following AstraZeneca’s application to extend use of the treatment and requested additional clinical data from it.

Fasenra was AstraZeneca’s first respiratory biologic and raked in $1.26 billion in sales in 2021, jumping 33% from the previous year. It belongs to a class of medicines called monoclonal antibodies and is used against severe asthma.

Register now for FREE unlimited access to Reuters.com

The treatment rivals GlaxoSmithKline’s (GSK.L) Nucala and Teva’s (TEVA.TA) Cinqair from the same drug class, while AstraZeneca has also developed a newer medicine, Tezspire, with Amgen (AMGN.O) which would compete with Fasenra.

An approval would have challenged Sanofi’s (SASY.PA) Dupixent and Novartis’s (NOVN.S) Xolair, the two biologic respiratory drugs that have so far won approval to treat chronic rhinosinusitis with nasal polyposis.

The setback for AstraZeneca’s Fasenra comes after the drugmaker said on Friday the FDA had approved its and Merck’s (MRK.N) cancer drug, Lynparza, as a treatment for patients with early-stage breast cancer with certain mutations. read more

Register now for FREE unlimited access to Reuters.com

Reporting by Pushkala Aripaka in Bengaluru and Ludwig Burger in Frankfurt; Editing by Rashmi Aich

Our Standards: The Thomson Reuters Trust Principles.

Galveston County News Online

© 2021 Galveston County News Online

Navigate Site

  • Disclosure
  • Privacy Policy
  • DMCA Policy
  • CCPA
  • Medical Disclaimer

Follow Us

No Result
View All Result
  • Home
  • DMCA Policy
  • Medical Disclaimer
  • Privacy Policy
  • Disclosure
  • CCPA
  • Terms of Use

© 2021 Galveston County News Online

We use cookies on our website to give you the most relevant experience by remembering your preferences and repeat visits. By clicking “Accept All”, you consent to the use of ALL the cookies. However, you may visit "Cookie Settings" to provide a controlled consent.
Cookie SettingsAccept All
Manage consent

Privacy Overview

This website uses cookies to improve your experience while you navigate through the website. Out of these, the cookies that are categorized as necessary are stored on your browser as they are essential for the working of basic functionalities of the website. We also use third-party cookies that help us analyze and understand how you use this website. These cookies will be stored in your browser only with your consent. You also have the option to opt-out of these cookies. But opting out of some of these cookies may affect your browsing experience.
Necessary
Always Enabled
Necessary cookies are absolutely essential for the website to function properly. These cookies ensure basic functionalities and security features of the website, anonymously.
CookieDurationDescription
cookielawinfo-checkbox-analytics11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Analytics".
cookielawinfo-checkbox-functional11 monthsThe cookie is set by GDPR cookie consent to record the user consent for the cookies in the category "Functional".
cookielawinfo-checkbox-necessary11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookies is used to store the user consent for the cookies in the category "Necessary".
cookielawinfo-checkbox-others11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Other.
cookielawinfo-checkbox-performance11 monthsThis cookie is set by GDPR Cookie Consent plugin. The cookie is used to store the user consent for the cookies in the category "Performance".
viewed_cookie_policy11 monthsThe cookie is set by the GDPR Cookie Consent plugin and is used to store whether or not user has consented to the use of cookies. It does not store any personal data.
Functional
Functional cookies help to perform certain functionalities like sharing the content of the website on social media platforms, collect feedbacks, and other third-party features.
Performance
Performance cookies are used to understand and analyze the key performance indexes of the website which helps in delivering a better user experience for the visitors.
Analytics
Analytical cookies are used to understand how visitors interact with the website. These cookies help provide information on metrics the number of visitors, bounce rate, traffic source, etc.
Advertisement
Advertisement cookies are used to provide visitors with relevant ads and marketing campaigns. These cookies track visitors across websites and collect information to provide customized ads.
Others
Other uncategorized cookies are those that are being analyzed and have not been classified into a category as yet.
SAVE & ACCEPT