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Biotech Stocks Facing FDA Decision In July 2021

ChemoCentryx
ChemoCentryx

On July 7, the FDA will decide whether or not to approve ChemoCentryx Inc.’s (CCXI) Avacopan for the treatment of anti-neutrophil cytoplasmic antibody (ANCA)-associated vasculitis.

ANCA-associated vasculitis (AAV) is a rare autoimmune disease characterized by inflammation and destruction of small blood vessels, which can result in organ damage and failure, with the kidney as the major target, and is fatal if not treated.

In May, an FDA panel had voted 9-9 on the first question, whether the efficacy data support approval of Avacopan for the treatment of adult patients with AAV (granulomatosis with polyangiitis (GPA) and microscopic polyangiitis (MPA)).

Granulomatosis With Polyangiitis (GPA) and Microscopic Polyangiitis (MPA) are two types of ANCA-associated vasculitis, or AAV.

On the second question, the Committee voted 10-8 that the safety profile of Avacopan is adequate to support approval of Avacopan for the treatment of adult patients with AAV (ANCA-associated vasculitis).

In the third and final question, the Committee voted 10-8 that the benefit-risk profile is adequate to support approval of Avacopan at the proposed dose of 30 mg twice daily for the treatment of adult patients with AAV.

Roche’s Rituximab is the only FDA-approved therapy for adult patients with GPA and MPA, i.e., the two rare forms of AAV.

If approved, Avacopan could achieve blockbuster sales, according to analysts.

CCXI closed Wednesday’s (Jun.23, 2021) trading at $12.76, down 1.01%.