No USFDA approval for AstraZeneca's treatment for chronic nasal condition
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.
New Delhi: - AstraZeneca Plc 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.
The treatment rivals GlaxoSmithKline's Nucala and Teva's 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 Dupixent and Novartis'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 Also - AstraZeneca's Young Health Program opens 3 Health Information Centres (HICs) in Bangalore
AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development, and commercialisation of prescription medicines in Oncology, Rare Diseases, and BioPharmaceuticals, including Cardiovascular, Renal & Metabolism, and Respiratory & Immunology. Based in Cambridge, UK, AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide.
Read Also - AstraZeneca and Merck's Lynparza gets USFDA nod
Disclaimer: This website is primarily for healthcare professionals. The content here does not replace medical advice and should not be used as medical, diagnostic, endorsement, treatment, or prescription advice. Medical science evolves rapidly, and we strive to keep our information current. If you find any discrepancies, please contact us at corrections@medicaldialogues.in. Read our Correction Policy here. Nothing here should be used as a substitute for medical advice, diagnosis, or treatment. We do not endorse any healthcare advice that contradicts a physician's guidance. Use of this site is subject to our Terms of Use, Privacy Policy, and Advertisement Policy. For more details, read our Full Disclaimer here.
NOTE: Join us in combating medical misinformation. If you encounter a questionable health, medical, or medical education claim, email us at factcheck@medicaldialogues.in for evaluation.