Tezepelumab, sold under the brand name Tezspire, is a human monoclonal antibody used for the treatment of

asthma Asthma is a common long-term inflammatory disease of the airways of the lungs. It is characterized by variable and recurring symptoms, reversible airflow obstruction, and easily triggered bronchospasms. Symptoms include episodes of wh ...

. Tezepelumab blocks thymic stromal lymphopoietin (TSLP), an epithelial cytokine that has been suggested to be critical in the initiation and persistence of airway inflammation. The most common side effects include arthralgia (joint pain) and pharyngitis (sore throat). Tezepelumab was approved for medical use in the United States in December 2021, and in the European Union in September 2022. The US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) considers it to be a

first-in-class medication A first-in-class medication is a prototype drug that uses a "new and unique mechanism of action" to treat a particular medical condition. While the Food and Drug Administration's Center for Drug Evaluation and Research tracks first-in-class medic ...

Medical uses

Tezepelumab is

indicated In medicine, an indication is a valid reason to use a certain test, medication, procedure, or surgery. There can be multiple indications to use a procedure or medication. An indication can commonly be confused with the term diagnosis. A diagnosis ...

for the add-on maintenance treatment of people aged twelve years and older with severe asthma.

History

Two main studies including over 1,500 adults and adolescents with inadequately controlled asthma showed that tezepelumab was effective in reducing the number of severe asthma flare‑ups. The benefits and side effects of tezepelumab were evaluated in two clinical trials of participants with severe asthma. All participants were taking their usual treatment for asthma. In addition, participants received new treatment with either tezepelumab or placebo. Neither the participants nor the investigators knew which treatment was given. The benefit of tezepelumab was assessed by measuring the frequency of asthma attacks (exacerbations) at the end of both 52 week trials in comparison to placebo. The FDA approved tezepelumab based on evidence from two clinical trials (NAVIGATOR and PATHWAY) of 1334 participants with severe asthma. The safety and efficacy of tezepelumab were evaluated in two clinical trials of participants with severe asthma. The trials were conducted in 24 countries (Argentina, Australia, Austria, Bulgaria, Brazil, Canada, Czech Republic, France, Germany, Hungary, Israel, Japan, Lithuania, Latvia, Russia, Saudi Arabia, Serbia, Slovakia, South Africa, South Korea, Taiwan, Ukraine, United States, and Vietnam).

Society and culture

Legal status

On 21 July 2022, the

Committee for Medicinal Products for Human Use The Committee for Medicinal Products for Human Use (CHMP), formerly known as the Committee for Proprietary Medicinal Products (CPMP), is the European Medicines Agency's committee responsible for elaborating the agency's opinions on all issues regar ...

(CHMP) of the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

(EMA) adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Tezspire, intended as add-on treatment in adults and adolescents with severe asthma. The applicant for this medicinal product is AstraZeneca AB. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. Tezepelumab was approved for medical use in the European Union in September 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

Research

It is being studied for the treatment of chronic obstructive pulmonary disease, chronic rhinosinusitis with nasal polyps,

chronic spontaneous urticaria Chronic spontaneous urticaria (CSU) also known as Chronic idiopathic urticaria (CIU) is defined by the presence of wheals, angioedema, or both for more than six weeks. The most common symptoms of chronic spontaneous urticaria are angioedema and hi ...

and

eosinophilic esophagitis Eosinophilic esophagitis (EoE) is an allergic inflammatory condition of the esophagus that involves eosinophils, a type of white blood cell. In healthy individuals, the esophagus is typically devoid of eosinophils. In EoE, eosinophils migrate t ...

(EoE). In

phase III trial The phases of clinical research are the stages in which scientists conduct experiments with a health intervention to obtain sufficient evidence for a process considered effective as a medical treatment. For drug development, the clinical phases ...

s, tezepelumab demonstrated efficacy compared to placebo for patients with severe, uncontrolled

. Structural studies by

X-ray crystallography X-ray crystallography is the experimental science of determining the atomic and molecular structure of a crystal, in which the crystalline structure causes a beam of incident X-rays to Diffraction, diffract in specific directions. By measuring th ...

showed that tezepelumab competes against a critical part of the TSLPR binding site on TSLP.

References

External links

* * {{Portal bar , Medicine Drugs developed by Amgen Drugs developed by AstraZeneca Monoclonal antibodies Orphan drugs Antiasthmatic drugs