Two Recent FDA and EMA Approvals Bring Hope to ANCA Associated-Vasculitis Patients

 

 ANCA-associated vasculitis (AAV) generally targets two enzymes, myeloperoxidase (MPO) or proteinase 3 (PR3) located in the granules of monocytes and neutrophils. These enzymes play a critical role in the defense against bacteria.

According to a recent article in LabioTech, symptoms of AAV include blood and protein in the urine, high blood pressure, respiratory issues, and fatigue. Inflammation in the trachea may also develop.

Steroid medication is currently the standard of care to suppress the immune system. However, there are serious side effects including risk of bone disorders, infections, hypertension, adrenal insufficiency, and cataracts. AAV can cause damage to the kidney or lungs and can therefore be life-threatening.

The developers of Avacopan have evaluated elevated levels of a protein called C5a. The new drug has been developed to block C5a action, resulting in fewer side effects.

Avacopan was approved by the FDA in October 2021 for the treatment of AAV. Avacopan will be marketed by ChemoCentryx under its brand name, Tavneos.

In November 2021 the Swiss firm Vifor Pharma received European Medicines Agency (EMA) approval for Avacopan to treat AAV. Vifor expects the EMA to give market approval for the drug in early 2022.

Additional targeted treatments for AAV are being developed for EMA approval as well as positive Phase II results from a rival company.

Nathalie Ponnier, Vifor Communications Officer, said that her company hopes to fulfill the need for innovative therapies to reduce the debilitating side effects of the current treatment for AAV.

Rose Duesterwald

Rose Duesterwald

Rose became acquainted with Patient Worthy after her husband was diagnosed with Acute Myeloid Leukemia (AML) six years ago. During this period of partial remission, Rose researched investigational drugs to be prepared in the event of a relapse. Her husband died February 12, 2021 with a rare and unexplained occurrence of liver cancer possibly unrelated to AML.

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