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FDA approves add-on drug for adults with rare form of blood vessel inflammation

Action

FDA has approved Tavneos (avacopan) as an add-on treatment to standard therapy including glucocorticoids for adult patients with severe active anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis. Tavneos helps to reduce blood vessel inflammation and offers patients an additional treatment for a disease with few treatment options. Tavneos does not eliminate the need for use of glucocorticoids.

Disease or Condition

ANCA-associated vasculitis is a rare autoimmune condition in which the immune system attacks small blood vessels in the body. As a result, patients can have symptoms throughout the body including in the kidneys and lungs. ANCA-associated vasculitis occurs in approximately 200 per million individuals.

Effectiveness

Safety and effectiveness of Tavneos were demonstrated in one study, where clinical trial participants with ANCA-associated vasculitis received Tavneos 30 mg twice daily for 52 weeks or prednisone taper (slowly decreasing amount) for 20 weeks. Both treatment groups also received background treatment with immunosuppressive drugs (cyclophosphamide or rituximab). Participants receiving Tavneos had a significantly higher percentage (65.7%) of sustained remission of ANCA-associated vasculitis symptoms at week 52 compared to patients in the control group (54.9%).

Safety Information

Tavneos is not recommended for patients with liver disease and cirrhosis. Health care professionals should obtain patient liver function tests before starting Tavneos and monitor patients as clinically indicated. Tavneos may cause angioedema, if angioedema occurs, patients should immediately stop use of Tavneos. Patients with a serious hypersensitivity reaction to Tavneos or its inactive ingredients must not take Tavneos. Reactivation of Hepatitis B virus occurred in patients using Tavneos. Patients with active, serious infections, should avoid using Tavneos.

See the prescribing information for additional information on risks associated with Tavneos.

Designations

Tavneos received orphan drug designation to treat ANCA-associated vasculitis.

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