February 02, 2023
1 min read
Dobber reports employment with AstraZeneca. Mendez reports employment with Asthma and Allergy Foundation of America.
The FDA has approved tezepelumab-ekko for self-administration in a prefilled, single-use pen among patients aged 12 years and older with severe asthma, according to a press release from the manufacturer.
Tezepelumab-ekko (Tezspire; AstraZeneca, Amgen) is the only biologic that has been approved for severe asthma with no phenotype (eg, eosinophilic or allergic) or biomarker limitation within its approved label.
“With the approval of the prefilled pen in the US, we can now offer greater flexibility to patients and physicians with the option to administer Tezspire at home or in the clinic,” Ruud Dobber, PhD, executive vice president and president of the biopharmaceuticals business unit at AstraZeneca, said in the press release.
The FDA based its approval on results from the PATHFINDER clinical trial, which included results from the PATH-BRIDGE phase 1 and PATH-HOME phase 3 trials.
In PATH-HOME, for example, 92% of health care providers and caregivers successfully administered tezepelumab-ekko via the pen in the clinic and at home, with improvements in asthma control and a safety profile consistent with previous clinical trials.
“Severe asthma continues to be a very complex condition to manage, so we welcome the Tezspire prefilled pen as an option that will empower patients and health care providers with increased choice,” Kenneth Mendez, MBA, president and CEO of the Asthma and Allergy Foundation of America, said in the press release.
“We believe self-administration alternatives can play an important role in patients’ lives and address unmet needs for those living with severe asthma,” Mendez continued.
The tezepelumab-ekko prefilled pen and self-administration have been approved in the European Union and are under regulatory review in other countries. Also, the US, European Union, Japan and other countries have approved tezepelumab-ekko for treating severe asthma.