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Antiasthma Drugs: Leukotriene Modifiers01:19

Antiasthma Drugs: Leukotriene Modifiers

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Leukotriene modifiers, or cysteinyl leukotriene receptor antagonists, are medications used to manage chronic asthma. These agents target specific inflammatory mediators produced during arachidonic acid metabolism, an essential process in generating inflammation in the body.
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The diagnosis and management of asthma are comprehensive, encompassing clinical assessments, lung function tests, and pharmacological interventions. Here's an overview:
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Antiasthma Drugs: Mast Cell Stabilizers and Anti-IgE Drugs01:25

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Asthma is a chronic respiratory condition for which new therapeutic avenues, including anti-inflammatory drugs like mast cell stabilizers and anti-IgE treatments, continue to be developed.
Mast cell stabilizers, such as cromolyn (also known as sodium cromoglycate) and nedocromil (Tilade), are effective drugs in asthma management. These stabilizers hinder histamine release by skillfully obstructing the activation of mast cells and other cellular entities. Notably, they navigate this task without...
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Bronchodilators are critical in managing asthma, a chronic respiratory condition characterized by airway constriction due to inflammation and hyper-reactivity. Specifically, bronchodilators ease this constriction by relaxing the bronchial muscles, facilitating easier breathing.
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Upper Respiratory Drugs: First and Second-Generation Antihistamines01:15

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Antihistamines are a class of drugs widely used to alleviate the symptoms of allergies, such as sneezing, itching, and nasal congestion. They work by inhibiting the actions of histamine, which is released by immune cells in response to allergenic substances or tissue injuries.
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Post-approval, manufacturers may modify an approved new or generic drug product. Such modifications can encompass alterations in the Active Pharmaceutical Ingredient (API), manufacturing process, formulation, batch size, manufacturing site, and container closure system (FDA Guidance for Industry, April 2004). Often, a drug product may undergo multiple changes.These modifications require careful evaluation to determine their potential impact on the drug product's identity, strength, quality,...
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Atezolizumab: First Global Approval.

Anthony Markham1

  • 1Springer, Private Bag 65901, Mairangi Bay, 0754, Auckland, New Zealand. dru@adis.com.

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Summary
This summary is machine-generated.

Atezolizumab, a PD-L1 inhibitor, shows promise in treating various cancers. Its development milestones led to its first US approval for urothelial carcinoma, with more indications pending.

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Area of Science:

  • Oncology
  • Immunotherapy
  • Drug Development

Background:

  • Atezolizumab is a monoclonal antibody targeting the PD-L1 pathway.
  • PD-L1 is an immune checkpoint protein implicated in tumor evasion.
  • Genentech is developing atezolizumab for diverse cancers.

Purpose of the Study:

  • To summarize the development of atezolizumab.
  • To highlight key milestones leading to its approval.
  • To focus on its initial approval for urothelial carcinoma.

Main Methods:

  • Review of preclinical and clinical development data.
  • Analysis of regulatory submission and approval processes.
  • Summary of clinical trial outcomes for urothelial carcinoma.

Main Results:

  • Atezolizumab targets programmed death ligand 1 (PD-L1).
  • US FDA approval granted for second-line urothelial carcinoma treatment.
  • Awaiting approval for non-small cell lung cancer.

Conclusions:

  • Atezolizumab represents a significant advancement in cancer immunotherapy.
  • The drug's development journey culminated in its first major regulatory approval.
  • Further applications in various malignancies are anticipated.