4 ms·
> For those stuck in the United States, the FDA will let you get Ocrelizumab, which is basically Rituximab tweaked enough so that Genentech could get patent pr
by adrianratnapala 8y ago
> For those stuck in the United States, the FDA will let you get Ocrelizumab, which is basically Rituximab tweaked enough so that Genentech could get patent protection for it.
So Rituximab was never approved by the FDA? I assume it too had once been under patent, and its manufacturer would have tried to get it approved.
- steelframe 8y agoIn the U.S., the FDA approves a drug for a particular use. Rituximab would have to undergo a complete set of clinical trials to show its safety and efficacy for MS in particular. Otherwise doctors can only prescribe it off-label, and the system (i.e., liability) is set up to dissuade doctors from prescribing drugs off-label if there exists a drug approved by the FDA for the particular purpose.