Sunday, August 7, 2016

Protein Kinase Inhibitors / Small Molecules in Rheumatology – an Update 2016

I have already written about hype or hope in protein kinase inhibitors. Tofacitinib seems to have the data needed, to get approval by EMEA in Europe, at least Pfizer applied for approval. So, in August 2016 I feel it’s time to ask again: where do we stand and how much hype is left?

The protein kinase inhibitors were introduced with high hopes and expectations, but the hype fell off, when EMEA asked for more data on tofacitinib. Now, about three years later, Pfizer has applied for approval of tofacitinib in Europe. And I see more activity on small molecules recently.
Due to introducing small molecules, we have learned much on what is driving inflammation in rheumatic diseases during the last decade.

Here is a chart, in which I put my updated knowledge:

Green – approved

Yellow – still in the race

Red – out of the race

Apremilast is approved in the US and the EU. Tofacitinib is appoved at least in the US and applied for approval in the EU. Baricitinib applied for approval in the US. Abt-494 is investigated in a phase 3 study (SELECT-COMPARE); OT: please name the child. Peficitinib (ASP015k) is investigated in Japan. EULAR 2016 has seen pahse 2b studies by decernotinib and filgotinib. I might have overrated HM-0523, as I am skeptical about about the value of Syk inhibitors in the therapy of rheumatoid arthritis and I haven't seen any new study after the ACR 2014 Meeting. All in all, more action to get small molecules to the market.

I guess that the pharmaceutical industry isn’t prudent enough not to overprice small molecules, so that our patient's needs are addressed. Prices should be oriented in the range of methotrexate and leflunomide.



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