FDA accelerated approval · New moleculeFirst dual BAFF and APRIL inhibitor40-second read
Trutaknaatacicept-vymj
Vera Therapeutics · BAFF and APRIL inhibitor (recombinant fusion protein) · Nephrology
Bottom line for your patients
Adults with primary IgA nephropathy at risk of progression have a new weekly self-injected option that lowered proteinuria in its pivotal trial. Its effect on long-term kidney function is not yet established.
Drug brief
Drug IQ- Who it is for
- Adults with primary immunoglobulin A nephropathy at risk for disease progression, to reduce proteinuria.
- What changes
- The company describes it as the first and only available therapy that binds both BAFF and APRIL. The pivotal trial compared it with placebo.
- The evidence
- In the prespecified 36-week interim analysis of the first 203 participants, Trutakna produced a 46% reduction from baseline in UPCR and a 42% reduction compared to placebo (p<0.0001).Placebo-controlled randomized trialORIGIN 3 · Phase 3 · 203 participantsRandomized against placebo: shows that it works, not how it compares with existing treatments.
- Watch for
- The most common adverse reactions were infections (32% vs 28% with placebo) and local administration reactions (30% vs 5%). The drug suppresses the immune system, live vaccines are not recommended within 30 days before or during treatment, and continued approval may depend on confirmatory results.
- How it is given
- Subcutaneous injection150 mg once weekly, self-administered by autoinjector
- What the approval tells you
- New molecule. An active ingredient the FDA had not approved before.Accelerated approval. Approved on a surrogate or intermediate endpoint reasonably likely to predict benefit. A confirmatory trial is required, and approval can be withdrawn if the benefit is not confirmed.