FDA Accepts NDA for Asundexian, Dysport Noninferior Botox in Safety Profile, gMG Bridging the Gaps Discussion

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Welcome to the Neurology News Network, my name is Louie Pasculli and here’s a look at the top stories in Neurology.

Beginning with FDA news, the administration has accepted Bayer’s New Drug Application (NDA) for asundexian, an investigational oral factor XIa (FXIa) inhibitor, and granted the therapy Priority Review for the prevention of recurrent stroke in patients following a non-cardioembolic ischemic stroke or transient ischemic attack (TIA). The regulatory submission was supported by positive findings from the pivotal phase 3 OCEANIC-STROKE trial, which demonstrated significant reductions in ischemic stroke risk without increasing major bleeding.^1,2

If approved, asundexian could become the first FXIa inhibitor indicated for secondary stroke prevention, representing a potentially important advance in antithrombotic therapy for a population that continues to face high rates of recurrent vascular events despite current standards of care.

“Secondary stroke remains a serious and persistent challenge, and the FDA’s Priority Review designation underscores the urgency of advancing potential new approaches in secondary stroke prevention,” Yesmean Wahdan, MD, senior vice president of U.S. Medical Affairs at Bayer, said in a statement.¹ “We are proud of this important milestone that builds on our long-standing commitment to innovation in anti-thrombotic therapies and look forward to collaborating with the FDA as we work to bring asundexian to patients in need.”

New late-breaking findings from the phase 4 DIRECTION trial (NCT04936542) showed that treatment with Dysport (abobotulinumtoxinA; Ipsen) demonstrated a noninferior safety profile to Botox (onabotulinumtoxinA; AbbVie) in adults with upper limb spasticity (ULS), while also providing a longer duration of response. The data, presented at the 2026 International Society of Physical and Rehabilitation Medicine (ISPRM) World Congress in Vancouver, marked the first prospective, randomized, double-blind head-to-head comparison between the 2 botulinum toxin type A therapies in spasticity.³

The DIRECTION study met both its primary safety endpoint and key secondary efficacy endpoint. Treatment-emergent adverse events occurred in 20.3% of patients treated with Dysport compared with 23.0% of those treated with Botox, yielding an adjusted treatment difference of –2.7% (80% CI, –6.2 to 0.9).³

In addition, patients receiving Dysport achieved a longer duration of therapeutic response than those treated with Botox, with treatment effects lasting 14.2 weeks versus 13.8 weeks, respectively (adjusted difference favoring Dysport; 80% CI, 0.2-5.9). Investigators noted that evidence of longer duration was consistent across most demographic and clinical subgroups.³

Finally, the therapeutic landscape for generalized myasthenia gravis (gMG) has shifted considerably in recent years, with 7 new medications approved in the past decade, 6 of which arrived within the last 4 years alone. Despite this, expanded treatment options have not totally resolved the field's most pressing clinical questions. Chief among them is how to select, sequence, and sustain therapies for patients whose disease defies simple categorization.

Against this backdrop, NeurologyLive convened a multidisciplinary global panel of neuromuscular specialists for a Bridging the Gaps consensus meeting. The group sought to examine persistent gaps in gMG diagnosis, treatment initiation, special populations, and equitable access to care. The meeting was chaired by James Howard, MD, of the University of North Carolina, Chapel Hill, and featured faculty from institutions across the United States, Italy, and Germany.

To read the full piece and to get more direct access to expert insight, head to NeurologyLive.com. Be sure to tune in next week to remain informed on the latest in neurology. I’m Louie Pasculli, thanks for watching Neurology News Network.

REFERENCES
1. 1. Bayer Granted Priority Review by U.S. FDA for Asundexian in Patients After a Non-Cardioembolic Ischemic Stroke or Transient Ischemic Attack. News release. Bayer. May 18, 2026. Accessed May 19, 2026. https://www.businesswire.com/news/home/20260518787299/en/Bayer-Granted-Priority-Review-by-U.S.-FDA-for-Asundexian-in-Patients-After-a-Non-Cardioembolic-Ischemic-Stroke-or-Transient-Ischemic-Attack
2. Sharma M, Dong Q, Hirano T, et al. Asundexian for secondary stroke prevention. N Engl J Med. 2026;394(15):1467-1479. doi:10.1056/NEJMoa2513880
3. Ipsen announces late-breaking data from first head-to-head study comparing Dysport® and Botox® in adults with upper limb spasticity. News release. Ipsen Pharma. May 19, 2026. Accessed May 20, 2026. https://www.businesswire.com/news/home/20260518787299/en/Bayer-Granted-Priority-Review-by-U.S.-FDA-for-Asundexian-in-Patients-After-a-Non-Cardioembolic-Ischemic-Stroke-or-Transient-Ischemic-Attack