@csrwin, Yes, rux was approved; rex is MSB's MPC product in cardiac indications and low back pain. Regarding insurance, we agree. Per my post ...38466 above: " For children with aGVHD that means Ryoncil is squarely positioned as a second-line therapy after steroids have failed... leaving open the question of what to do for children 12 and above. That means it's up to the clinician (with input from insurance most likely) to decide whether Ryoncil should be used before ruxilitinib..."
Pending further trials this will play out in actual practice... the cheapest med/dose doesn't always win if there are significant advantages from the more expensive product. NOAC's displacing warfarin in A fib are an example. That said, based on the Nov 2023 PR, it sounds like the company may be willing to cede second-line therapy in adults to ruxilitinib. Let's see if that changes going forward.
@manishv, Ryoncil has some adult data; it was presented at a recent conference. They also have adult GVHD data using the precursor product Prochymal, that I believe helped define the CQA's and the spectrum of potency assay data needed for Ryoncil approval. As for holding the Company accountable, bravo, I'm all for it. You can read my posts on the thread about replacing the CEO. Meanwhile, it's a message board with lots of room for a variety of content... from the serious to the light-hearted including pictures of puppy dogs and even the rear end of a horse. I'll stop there. Peace.
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