……….catching up on FDA approvals
We usually don’t report on expanded indications for a therapy previously approved by the FDA.
This time one such approval is noteworthy.
It is not uncommon that a new therapy comes to market and, within months, then applies for an expanded indication. There is a pattern wherein the initial NDC is often for a rare / orphan condition that is fast-tracked enabling supplemental filings to also be fast-tracked. The new approval of Kevzara is a clear exception to that rule.
Way back in 2017 the FDA approved Kevzara (sarilumab), from Sanofi, indicated for the treatment of adult patients with moderately to severely active rheumatoid arthritis. Clinical trials started post-approval to include juvenile arthritis.
Like the Energizer Bunny….. Sanofi kept going and going and going in the ensuing 7 years to expand the 2017 indication….. and succeeded. They finally received approval for the treatment of individuals with active polyarticular juvenile idiopathic arthritis (pJIA). pJIA is a form of arthritis that affects multiple joints at one time.
As Kevzara is a sub-q therapy, specialty pharmacies may be alert to distribution opportunities.
CLICK HERE to access prescribing information
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FDA Approves Sarilumab for Active Polyarticular Juvenile Idiopathic Arthritis
