📰 First new CIDP drug since the Clinton administration
⚡ Stiff Person Syndrome about to get the first FDA-approved treatment EVER
🧬 ALS patients showing actual improvement—not just slower decline
💰 Your 2026 Medicare survival guide (Texas is in a new pilot—read this)
❌ Progressive MS setback: What the tolebrutinib rejection means

⏱ Read time: 4 minutes

On December 22, 2025—eight days ago—the FDA approved Vyvgart Hytrulo for CIDP.

The last time a fundamentally new treatment approach hit CIDP, Bill Clinton was president, Friends hadn't aired yet, and most of you hadn't been diagnosed.

Why this isn't just another drug approval:

IVIg works. But it works like a sledgehammer when you need a scalpel. You sit in a chair for hours. You feel like garbage for days. And you do it again. And again. Forever.

Vyvgart Hytrulo is an FcRn blocker—it targets the specific receptor recycling the antibodies attacking your nerves. The ADHERE trial (the largest CIDP trial ever run) showed 61% reduction in relapse risk. Patients improved regardless of what they'd tried before.

The practical difference that matters:

A 30-to-90-second injection. Under your skin. Once a week. At home. On your couch. On your schedule.

No infusion center. No lost days. No feeling like you got hit by a truck.

Texas access:

Houston Methodist, UT Southwestern, and Baylor have FcRn blocker experience from myasthenia gravis. The infrastructure exists. But insurance authorization takes time—start the conversation NOW.

🎯 Call your neurologist Monday morning. Not next week. Monday. Ask: "Am I a candidate for Vyvgart Hytrulo, and what's the prior auth timeline?"

Two weeks ago, Kyverna Therapeutics dropped data that rewrites the playbook.

Their CAR-T therapy miv-cel hit every endpoint in the registrational KYSA-8 trial for stiff person syndrome. They're filing for FDA approval in the first half of 2026.

The numbers that stopped us cold:

This is a disease with ZERO FDA-approved treatments. Patients have been managing with benzodiazepines and hope. Now a single infusion is giving people their legs back.

If approved, miv-cel becomes the first CAR-T therapy approved for ANY autoimmune disease—not just the first SPS treatment.

🎯 If you have SPS: Get on notification lists NOW. Contact the Stiff-Person Syndrome Research Foundation (stiffperson.org) or your neuromuscular specialist. When this gets approved, demand is going to be massive.

Published December 22 in JAMA Neurology: Long-term data from the tofersen (Qalsody) trial shows something we don't say about ALS.

Improvement.

Not "slower decline." Not "stabilization." About 25% of patients with SOD1-ALS showed actual improvement in strength and mobility over 3-5 years.

One patient, Rickey Malloy from the WashU Medicine trial site, is playing golf with his family.

This is a disease that takes everything. Tofersen is giving some of it back.

For SOD1-ALS families: If you carry an SOD1 mutation but don't have symptoms yet, a prevention trial is now enrolling. Ask your neurologist or contact the ALS Association.

New year, new rules. Here's what changed January 1 that directly affects rare neuro families in Texas:

The good news:

✅ $2,000 out-of-pocket cap on Part D drugs — First time ever. Once you hit it, you pay nothing for covered prescriptions the rest of the year.

✅ Drug price negotiations in effect — 10 medications now have negotiated prices. Check if yours is on the list at medicare.gov.

✅ Medicare Prescription Payment Plan — Spread your drug costs monthly instead of getting slammed in January. You have to opt in.

The heads-up for Texas:

⚠️ Texas is in the WISeR prior authorization pilot — Starting 2026, certain Part B services now require advance approval in original Medicare (not just Medicare Advantage). This affects some DME and procedures. If you're denied, you have appeal rights—use them.

The cost increases:

🎯 Action steps:

Bad news deserves straight talk.

On December 24, the FDA issued a Complete Response Letter for tolebrutinib—Sanofi's brain-penetrating BTK inhibitor for non-relapsing secondary progressive MS. This was supposed to be the first drug targeting "smoldering" neuroinflammation in progressive MS.

The rejection doesn't mean the science failed. It means the FDA wants more—possibly more safety data, possibly clearer benefit-risk. Sanofi says they'll work with FDA on a path forward.

For progressive MS patients who were waiting: This hurts. But the drug is approved in the UAE and under review in Europe. The door isn't closed—it's just slower.

UT Southwestern Neuromuscular: 214-645-8800
Houston Methodist Neuromuscular: 713-363-7310
Texas SHIP (Medicare help): 1-800-252-9240
ALS Association Texas: als.org
Stiff-Person Syndrome Research Foundation: stiffperson.org

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MEDICAL DISCLAIMER: This newsletter provides educational information reviewed by our medical advisory board. Content is not intended as medical advice. Always consult your healthcare provider before making treatment decisions. Clinical trial information is provided for educational purposes - eligibility and enrollment should be discussed with qualified medical professionals.

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