Priority Review for AstraZeneca and Amgen's first-in-class asthma biologic

8 July 2021
astrazeneca_big-1

AstraZeneca (LSE: AZN) says that the US regulator has accepted for Priority Review its Biologics License Application (BLA) for tezepelumab, developed in collaboration with Amgen (Nasdaq: AMGN).

The US Food and Drug Administration will now provide a decision on the submission during the first quarter of 2022.

Tezepelumab is a potential first-in-class treatment for asthma, which has demonstrated superiority in a broad population of severe asthma patients, compared to placebo when added to standard of care.

This article is accessible to registered users, to continue reading please register for free.  A free trial will give you access to exclusive features, interviews, round-ups and commentary from the sharpest minds in the pharmaceutical and biotechnology space for a week. If you are already a registered user please login. If your trial has come to an end, you can subscribe here.

Login to your account

Become a subscriber

 

£820

Or £77 per month

Subscribe Now
  • Unfettered access to industry-leading news, commentary and analysis in pharma and biotech.
  • Updates from clinical trials, conferences, M&A, licensing, financing, regulation, patents & legal, executive appointments, commercial strategy and financial results.
  • Daily roundup of key events in pharma and biotech.
  • Monthly in-depth briefings on Boardroom appointments and M&A news.
  • Choose from a cost-effective annual package or a flexible monthly subscription
The Pharma Letter is an extremely useful and valuable Life Sciences service that brings together a daily update on performance people and products. It’s part of the key information for keeping me informed

Chairman, Sanofi Aventis UK

Companies featured in this story

More ones to watch >


Today's issue

Company Spotlight





More Features in Biotechnology