FDA Approves Tezspire for Self-Administration With New Prefilled Pen

The Food and Drug Administration (FDA) has approved a new prefilled, single-use pen for Tezspire^™ (tezepelumab-ekko) for the add-on maintenance treatment of patients 12 years of age and older with severe asthma.

Following proper training in subcutaneous injection technique by a health care provider, the 210mg/1.91mL (110mg/mL) prefilled pen can be administered by patients or caregivers at home or in a clinic. The approval was based on data from the PATHFINDER clinical trial program, which included the phase 1 PATH-BRIDGE trial (ClinicalTrials.gov Identifier: NCT03989544) and the phase 3 PATH-HOME trial (ClinicalTrials.gov identifier: NCT03968978). Findings from PATH-HOME showed that the majority of study participants (aged 12 to 80 years) were able to successfully administer tezepelumab at home or in the clinic.

“People with severe asthma will now have the flexibility to administer Tezspire at home or continue to receive their medicine in their doctor’s office,” said Murdo Gordon, executive vice president of Global Commercial Operations at Amgen. “This approval reinforces our continued efforts to improve accessibility to Tezspire, a first-in-class medicine proven to consistently and significantly reduce exacerbations across a broad population of people with severe asthma.”

Tezspire is also supplied in a single-dose vial or prefilled syringe containing 210mg/1.91mL (110mg/mL) of tezepelumab-ekko for administration by a health care provider.

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