MFDS Approves AZ Severe Asthma Treatment New Drug 'Tezspire'

The Ministry of Food and Drug Safety announced on the 21st that it has approved AstraZeneca (AZ)'s new drug for severe asthma treatment, Tezspire (active ingredient Tezepelumab).

AstraZeneca (AZ)'s new drug for severe asthma treatment, Tezspire (active ingredient Tezepelumab) [Photo by AstraZeneca]

Tezspire is an anti-TSLP monoclonal antibody therapy that binds to thymic stromal lymphopoietin (TSLP), which causes airway inflammation. TSLP is a type of cytokine, a signaling molecule that induces immune responses, expressed by epithelial cells in the thymus, lungs, skin, and other tissues in response to external antigen stimulation, causing inflammation. Tezspire reduces a wide range of inflammation-related biomarkers and cytokines by blocking TSLP.

Notably, Tezspire is the first therapy approved with an anti-TSLP mechanism. Existing severe asthma treatments have been developed targeting immune globulin E (IgE) of mast cells or interleukin (IL)-5, among others.

Tezspire has been approved as an additional maintenance treatment for severe asthma patients aged 12 and older whose condition is not adequately controlled by existing therapies. A 210 mg dose is administered subcutaneously every 4 weeks.

In clinical trials, subcutaneous injection (SC) of Tezspire every 4 weeks showed reductions in blood eosinophil counts, interleukin (IL)-5 and IL-13 concentrations, and serum immunoglobulin (Ig)E levels compared to placebo. Except for the slowly decreasing IgE, these markers showed near maximal suppression two weeks after treatment and the effects were sustained throughout the treatment period.