Genmab — Juni 2020

[GeorgeBest]

Jeps

[E_L]

As FDA warns on delays, a big Novartis approval stalls – coincidence? https://www.evaluate.com/vantage/articles/news/snippets/fda-warns-delays-big-novartis-approval-stalls-coincidence

[E_L]

"The project [ofatumumab], which has been reformulated for subcutaneous delivery, is pegged as the company’s most important sales growth driver over the coming years, according to sellside consensus"

[troldmanden]

Det er per definition aldrig en positiv ting at FDA har følt sig nødsaget til at bede om flere data. Det øger risiko for de afviser den. De er ofte noget på bivirkninger og subgrupper af patienter som FDA ikke mener er godt nok belyst i det oprindelige indsendte. Så jeg vil helt sikkert sige det er en dårligere nyhed end 1 mdr hurtiger SC godkendeles af dara i EU

[royal]

EL, do you think they will "punish" them?

[gentogen]

Det med de 15 gange bedre Mim-8 stammer fra; "Mim8 - a Next-Generation FVIII Mimetic Bi-Specific Antibody - Potently Restores the Hemostatic Capacity in Hemophilia a Settings in Vitro and In Vivo"

[gentogen]

Mim8 was capable of normalizing thrombin generation and blood clot formation, respectively, with approximately 15 times greater potency than emicizumab

[gentogen]

A similar potency improvement was demonstrated in a tail vein transection bleeding model in FVIII-deficient mice

[gentogen]

Just a moment...

(ashpublications.org)

[Bulder]

Medicinrådet: Det er en fordel for patienterne, at emicizumab kan administreres som subkutan injektion hver uge, hver
anden eller hver fjerde uge sammenlignet med standard FVIII- og EHL-præparater, der administreres som
intravenøs infusion flere gange om ugen. https://medicinraadet.dk/media/yr2czsxb/medicinraadets-vurdering-af-klinisk-merværdi-vedr-emicizumab-til-haemofili-a-vers-1-0_adlegacy.pdf side 16

[Bulder]

Hvis så ydermere mim8 kan gives i "small volumes in a pen device". Peger det på yderligere fordele i form af hjemmeadministration.

[Bulder]

Plus "15 times greater potency".

[E_L]

@roldmanden without more information it is hard to judge if it is bad news or just a delay ; in every review there will be interaction between both parties & additional questions asked by the FDA, mabye it just went slower due to time constraints (which the FDA have recently indicated could happen) we just don't know (yet?)

[E_L]

Let's hope they don't @royal ; even if they do, they will never admit it, but the first thing I thought when I heard about Novartis' problems with the FDA last year was 'I hope that doesn't impact Ofa..." (but i can be a bit cynical sometimes )

[Bulder]

Epcoritamab på dansk ("lovende"): https://haematologisktidsskrift.dk/sygdomme/lymfoma/720-subkutant-bispecifikt-cd3-cd20-antistof-mulig-konkurrent-til-car-t.html

[Helge_LarsenPI-redaktør]

Tusinde tak Bulder for en rigtig god artikel. Jeg har den i debatten.

[Helge_LarsenPI-redaktør]

lagt

[BioShare]

Super artikel Bulder...tak, det lyder virkelig lovende. Spændende at følge i forhold til CAR-T. “Lige så effektiv...og mere sikker”.

[lahn1]

Det lyder lovende, Bulder

[transalp]

Go morgen og tak for god læsning der, bulder..