IL 18 Binding Protein (tadekinig alfa) gets Breakthrough Therapy and Orphan status from FDA

The Swiss biotech company AB2Bio has been working for some time on tadekinig alfa, a medicine that blocks the IL18 pathway. Today they received news that the medicine has been granted both “Breakthrough Therapy” and “Orphan” status by the FDA.

What does this mean for SJIA? Well, IL18 seems to be an important pathway in MAS, which is the mostdangerous side-effect of SJIA. So blocking the IL18 pathway might be a useful treatment for patients with SJIA. But the drug has NOT been approved yet (although the Phase I and Phase II clinical trials so far have shown an excellent safety profile). “Breakthrough Therapy” status means that the FDA will work with the company to expedite the approval process. And “Orphan” Status means that they will get tax credits for clinical testing, and won’t have to pay certain fees to the FDA.

The drug is being tested for HLH and other life-threatening conditions of severe systemic autoinflammation.Clinical trials are also being done in Adult-Onset Stills Disease (which is essentially SJIA in adults).

We don’t know when tadekinig alfa will be available in the US, but this news definitely means it will be arriving on an accelerated timetable. We’ll let you know more as we find out more!