USA — The U.S. Food and Drug Administration (FDA) has granted approval to Amgen and AstraZeneca’s Tezspire for self-administration using a single-use, pre-filled pen for severe asthma patients aged 12 years and above.
Being jointly developed by AstraZeneca and Amgen, Tezspire is a first-in-class human monoclonal antibody and inhibits thymic stromal lymphopoietin (TSLP), an important epithelial cytokine that plays a vital role in multiple inflammatory cascades.
It was initially FDA-approved in December 2021 and is claimed to be the only biologic approved to treat severe asthma with no phenotype or biomarker limitation.
Tezspire will be given as a fixed-dose 210mg subcutaneous injection every four weeks, using a single-use, pre-filled auto-injector or through a pre-filled, single-use syringe.
The regulatory approval was based on the results obtained from the PATHFINDER clinical trial program that included data from the Phase I PATH-BRIDGE and the Phase III PATH-HOME trials.
In the PATH-HOME trial, 92% of healthcare providers, patients, and caregivers successfully administered Tezspire in the clinic and at home throughout the study.
Asthma control improvement and safety profile were consistent with previous clinical trials. Pharyngitis, arthralgia, and back pain are the most common adverse reactions of the antibody.
The antibody has already been approved for the same indication in Japan, the EU, the U.S., and other countries.
Meanwhile, Amgen Inc. recently launched a biosimilar version of AbbVie Inc’s big-selling arthritis treatment, the first such competition for Humira in the United States.
Amgen’s Amjevita is the first in a string of nine biosimilars—closely related versions of a biologic drug that function comparably—from several firms that are becoming available in the coming year.
Drug developers are closely watching Amjevita’s sales performance in the next few months will indicate the market’s appetite for biosimilars across the US pharmaceutical industry.
Since Humira’s 2003 launch by Abbott Laboratories, which later spun out AbbVie into a pure-play drugmaker, the medicine has become a standard treatment option for nine autoimmune conditions, including rheumatoid arthritis, plaque psoriasis, and ulcerative colitis.
AbbVie’s steady expansion of its use helped drive the blockbuster sales for which it is now known.
In other development, Amgen Inc. is laying off 300 U.S. employees, citing “industry headwinds” amid a down market for biopharma.
According to its most recent annual regulatory filing with the US Securities and Exchange Commission, the company had approximately 24,200 employees in over 50 countries as of December 31, 2021.
Amgen’s decision to reduce its workforce demonstrates how rapid interest rate hikes and a fading boom in demand following the pandemic have begun to weigh on the healthcare sector.
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