tiprankstipranks
Amgen’s Tezspire approved in U.S. for self-administration in severe asthma
The Fly

Amgen’s Tezspire approved in U.S. for self-administration in severe asthma

Amgen (AMGN) and AstraZeneca (AZN) announced FDA approval of Tezspire for self-administration in a pre-filled, single-use pen for patients aged 12 years and older with severe asthma. First approved by the FDA in December 2021, Tezspire is the only biologic approved for severe asthma with no phenotype or biomarker limitation within its approved label. In 2020, Amgen and AstraZeneca updated the 2012 collaboration agreement for TEZSPIRE. Both companies will continue to share costs and profits equally after payment by AstraZeneca of a mid-single-digit royalty to Amgen. AstraZeneca continues to lead development and Amgen continues to lead manufacturing. Amgen and AstraZeneca will jointly commercialize Tezspire in North America. The majority – 92% – of healthcare providers, patients and caregivers were able to successfully administer Tezspire both in the clinic and at home throughout the PATH-HOME trial. Tezspire self-administration and the Tezspire pre-filled pen are also approved in the European Union and are under regulatory review in several other countries around the world.

Published first on TheFly

See today’s best-performing stocks on TipRanks >>

Read More on AMGN:

Trending

Name
Price
Price Change
S&P 500
Dow Jones
Nasdaq 100
Bitcoin

Popular Articles