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@moatrx • one week ago • comments: 0

Posted a new blog:
US MYASTHENIA GRAVIS LAUNCH READINESS

A new gMG agent must address FcRn-inadequate responders or claim a serostatus niche efgartigimod's dominance has left open. Efgartigimod (Vyvgart/Vyvgart Hytrulo)...

@moatrx • one week ago • comments: 0

Posted a new blog:
UK MYASTHENIA GRAVIS LAUNCH READINESS

NICE's eculizumab appraisal was terminated before any cost-effectiveness review ran, leaving 2,000 to 3,000 UK gMG patients without a commissioned biologic....

@moatrx • one week ago • comments: 0

Posted a new blog:
GCC MYASTHENIA GRAVIS LAUNCH READINESS

Refractory gMG in the GCC is a 200 to 300 patient market run by fewer than 15 named neurologists, not a clinical proof problem. Efgartigimod (Vyvgart) was recently...

@moatrx • one week ago • comments: 0

Posted a new blog:
US IGA NEPHROPATHY LAUNCH READINESS

eGFR-confirmed evidence, not a second accelerated approval on UPCR surrogate data, resolves payer caution in IgA nephropathy. Budesonide (Tarpeyo, roughly 60%...

@moatrx • one week ago • comments: 0

Posted a new blog:
UK IGA NEPHROPATHY LAUNCH READINESS

NICE will not accept a UPCR-only case for IgA nephropathy; eGFR slope and mandatory SGLT2i background decide NHS access. Budesonide (Tarpeyo,...

@moatrx • one week ago • comments: 0

Posted a new blog:
GCC IGA NEPHROPATHY LAUNCH READINESS

Neither Tarpeyo nor Filspari is SFDA-registered in the GCC, so first filing, not better trial data, will set the IgA nephropathy standard of care. As of 2024,...

@moatrx • one week ago • comments: 0

Posted a new blog:
US HEREDITARY ANGIOEDEMA LAUNCH READINESS

Growing the never-prophylaxed HAE cohort beats switching stable lanadelumab patients, before donidalorsen's 69% attack-reduction data resets the oral bar....

@moatrx • one week ago • comments: 0

Posted a new blog:
UK HEREDITARY ANGIOEDEMA LAUNCH READINESS

HAE's real opportunity isn't switching lanadelumab patients, it's reaching the 1,500 to 2,500 UK patients who qualify for prophylaxis but have never received it....

@moatrx • one week ago

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@moatrx • 2 weeks ago • comments: 0

Posted a new blog:
GCC HEREDITARY ANGIOEDEMA LAUNCH READINESS

Fewer than 15% of GCC HAE patients are on any prophylaxis versus 35 to 40% in the US, making this category creation, not share capture. An estimated 400-600 GCC...

@moatrx • 2 weeks ago • comments: 0

Posted a new blog:
US GAUCHER DISEASE LAUNCH READINESS

Five approved Type 1 Gaucher therapies treat the body, not the brain, while a 45-patient gene therapy trial races to close that gap. Five FDA-approved therapies...

@moatrx • 2 weeks ago • comments: 0

Posted a new blog:
US FABRY DISEASE LAUNCH READINESS

Only 200 to 400 US Fabry patients define the ADA-positive niche left open by agalsidase failure, with one competitor and one testing bottleneck. Agalsidase beta...

MoatRx