AstraZeneca, Amgen's Tezspire Pre-filled Pen Receives FDA Approval In US For Asthma

AstraZeneca Plc (AZN) and Amgen Inc (AMGN)'s Tezspire got FDA approval in the US, based on the pathfinder clinical trial program.

The approval is for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. Tezspire is currently approved for the treatment of severe asthma in the US, EU, Japan, and other countries.4-6

AstraZeneca said 92 percent of healthcare providers, patients and caregivers were able to successfully administer Tezspire in the clinic and at home throughout the PATH-HOME trial.

Earlier Tezspire self-administration and the pre-filled pen got approval in the European Union.

For comments and feedback contact: editorial@rttnews.com

Business News

Editors Pick
The US Food and Drug Administration has cleared cultivated chicken developed by GOOD Meat Inc., the cultivated meat division of alternative foods startup Eat Just Inc. This is FDA's second pre-market consultation for a human food made from cultured animal cells after UPSIDE Foods. GOOD Meat is now required to meet Federal requirements including approvals from the US Department of Agriculture. A group of 23 U.S. states attorneys general have asked South Korean car manufacturers Hyundai Motor and Kia Corp. to take action more quickly to solve problems with millions of U.S. vehicles facing theft. The issue is related to the companies' failure to equip vehicles with anti-theft immobilizers, which has been a standard equipment on vehicles sold by other major manufacture El Monte, California-based Mutual Trading Co., Inc. is recalling certain Kagome Sauces citing undeclared soy, a known allergen, the U.S. Food and Drug Administration said. The recall involves 60 fl oz of Kagome Worcester Sauce, 10 fl oz of Kagome Chuno sauce, and 8g of Kagome Take out Tonkatsu Sauce.
Follow RTT