Because... Adult Gvhd is 5 times the number of patients than...

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dachopper

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17/04/24

19:52

Post #: 73394684
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Originally posted by Stellowe: ↑

but why would he refer to labelling being so important for safety for much more wider use, if he's thinking it will only be available in a handful of hospitals where they have training with gvhd.

administration is a simple thaw and IV process. (excluding targeted delivery)
what safety risk would doctors be concerned with
ards trial was administered in 21 hospitals so there is at least that many with experience..

i think off label use could expand quicker than some people are expecting. maybe not as big as ozempic for weight loss. there just isn't enough resources to run trials for every inflammatory condition. but evidence from off label use could be as powerful.

Off-label practice constitutes a starting point for future research and directions into marketing certain drug products for new indications, shifting to drug repurposing. There have been cases in which off-label use led to drug repurposing [48]; however, in most of the cases, the drug repurposing is triggered by serendipitous discoveries (e.g., thalidomide, *word disallowed by google). *word disallowed by google has been originally approved for pulmonary hypertension and then repurposed for erectile dysfunction [96]. Contradictorily, off-label practice could also lead to off-label use. In the European regulatory framework, drug repurposing can be translated into clinical practice in two ways: approving the new indication and granting market authorization or allowing the new indication to be off-label, based on national regulations [62,97]. All these considered, a repurposed drug product will not necessarily be exempted from off-label use, i.e., a pharmaceutical company approves the new indication, yet the availability of other generic drugs can still lead to off-label use of the generic drugs, if the approved drug is not specifically requested as prescriber’s means to an end [97]. Furthermore, if a certain company does not invest in developing the new therapeutic indication, the off-label prescribing of their product may be beneficial, as it expands the addressability to new categories of patients, without having to apply for a new marketing authorization [97].

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Because... Adult Gvhd is 5 times the number of patients than pediatric, so in my opinion just adult gvhd would constitute extremely widespread use, in fact may easily have more patients than the intended label with children.

it has a dosing regimen that could be used directly from pediatric gvhd too. Probably the same doctors in the same clinic, and plenty of EAP data to support potential evidence

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