Annexon Advances Guillain-Barré Syndrome Awareness and Introduces Groundbreaking Targeted Therapy

Breakthrough Therapy:
Annexon has developed tanruprubart (formerly ANX005), a first-of-its-kind targeted therapy that inhibits C1q to stop neuroinflammation in Guillain-Barré Syndrome (GBS). It demonstrated rapid and durable benefits in a pivotal Phase 3 trial1 3 6.

Phase 3 Results:
A single infusion of tanruprubart led to a 2.4-fold higher likelihood of health improvement versus placebo at Week 8 and resulted in accelerated recovery — patients regained mobility one month earlier and required less intensive care compared to standard treatments like IVIg or plasma exchange (PE)1 4 6.

Global Impact:
GBS affects approximately 150,000 people annually, and there are no FDA-approved treatments. Tanruprubart represents a significant advancement in addressing this unmet need1 3 6.

Real-World Evidence:
A complementary Real World Evidence (RWE) study reinforced the efficacy of tanruprubart, showing superior outcomes in muscle strength and recovery compared to standard treatments1 4.

FDA Submission:
Annexon plans to submit a Biologics License Application (BLA) for tanruprubart in the first half of 2025, aiming for regulatory approval as the first targeted GBS therapy2 6.

Education Campaign:
The "Move GBS Forward™" campaign was launched to raise awareness among healthcare professionals about GBS's impact and the importance of early diagnosis and treatment. The campaign uses impactful imagery and educational resources to highlight the disease's life-altering effects1 3 6.

Mechanism of Action:
Tanruprubart is designed to block the complement pathway's initiating molecule, C1q, to prevent nerve damage during acute phases of GBS, allowing quicker functional recovery6 9.

Improved Quality of Life:
The therapy reduces ICU stays and mechanical ventilation reliance, addressing both medical and economic challenges associated with GBS care1 4.

Durability of Results:
Benefits of tanruprubart were maintained through six months in trial settings, showcasing its potential for long-term efficacy1 4 6.