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Posted On: 06/05/2025 2:22:02 PM
Post# of 154652
Re: craigakess #153865
im the most ignorant person here - and curious about the evolution and databases of off label use of approved drugs, in general, across the industry - could be an interesting book subject..... and does it ever lead to being approved for the off label indication?
the ozempic / wegovy semaglutide story is different here because the side effect of weight loss in diabetes patients was a directly observable obvious positive(?) benefit of using the drug. im more interested in theoretical off label uses that werent simply an accidental observable result of use...although many have commented here wondering if the 1000 or so HIV patients that got to use leronlimab for years at a time had any other observable benefits like lower covid deaths, lower rates of metastatic cancers, lower HIV transmission rates, lower levels of liver fibrosis etc etc etc...all data that was never collected apparently? i understand that even the patients themselves were difficult to track down as per the amarex nonsense.
how does an approved drug even start to be used off label for a different indication in the first place? is it patient driven demand or is it scientist/doctor driven? is it always an observable beneficial side effect? is it in the drug companys' benefit, or even legal, to sell to the off label patients at a discount, as the insurance cos refuse to pay?
is there a database of off label drugs, their off label indications, and their sales numbers?
i have a sneaky suspicion that once leronlimab is approved for its first indication, off label prescription numbers will be huge. for a long list of indications.
the ozempic / wegovy semaglutide story is different here because the side effect of weight loss in diabetes patients was a directly observable obvious positive(?) benefit of using the drug. im more interested in theoretical off label uses that werent simply an accidental observable result of use...although many have commented here wondering if the 1000 or so HIV patients that got to use leronlimab for years at a time had any other observable benefits like lower covid deaths, lower rates of metastatic cancers, lower HIV transmission rates, lower levels of liver fibrosis etc etc etc...all data that was never collected apparently? i understand that even the patients themselves were difficult to track down as per the amarex nonsense.
how does an approved drug even start to be used off label for a different indication in the first place? is it patient driven demand or is it scientist/doctor driven? is it always an observable beneficial side effect? is it in the drug companys' benefit, or even legal, to sell to the off label patients at a discount, as the insurance cos refuse to pay?
is there a database of off label drugs, their off label indications, and their sales numbers?
i have a sneaky suspicion that once leronlimab is approved for its first indication, off label prescription numbers will be huge. for a long list of indications.
Quote:
Pardon my potential ignorance, but how could a licensee "mothball a LL indication"?
Once a drug is approved by the FDA for at least one use, healthcare providers can use their medical judgment to prescribe it for other medically appropriate purposes, even if those uses are not on the approved labeling.
Off-label prescribing is a common practice in medicine, with some estimates suggesting that 1 in 5 prescriptions written are for off-label uses. Of course CYDY (or the licensee) could not tout LL for an indication that it was not approved for.
Sure, maybe some insurance companies won't pay for it off-label, but that won't mean that people cannot get it some way.
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