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06-09-2021 | Systemic lupus erythematosus | Video | Article

FDA approval of anifrolumab for SLE


Eric Morand gives his thoughts on the FDA approval of anifrolumab for SLE and discusses the need for additional studies to understand exactly how the drug should be used in routine clinical practice


I think myself and rheumatologists and clinicians treating lupus around the world are very excited about the approval of anifrolumab by the FDA-- it's also been approved by the way in France-- it it's not that the FDA controls the regulatory approval in other countries but a negative outcome would have been most unhelpful for access to the drug in other places like Australia where I am, which is still going through approval process. 

I think it validates the interferon targeting hypothesis for lupus to see this approved and available for use I think that the FDA must have taken a very nuanced view of the total data set. As we discussed before one of the phase three trials formal primary endpoint was negative. The totality of the evidence shows a strong tilt towards efficacy across multiple measures across three trials, but formally speaking one of those two pivotal trials was negative, so there was always a risk that a very doctrinaire approach could have refused approval but I think myself and my colleagues feel that a more nuanced approach was needed and it looks like it's been taken. 

The the label that's been given appears to approve the use of the drug in people with moderate-to-severe active lupus, which is the right group, it's not been limited in that ruling to only severe cases which I think is the correct outcome. And then how that translates to the rest of the world will be done, as you know, on a jurisdiction by jurisdiction basis and in some of those places efficacy and safety are the only considerations any others like the UK and here in Australia cost benefit, cost effectiveness are also key factors in access to care so we'll have to wait and see how that plays out in terms of how that helps us with future trial endpoints-- i don't think it helps or hinders-- what i hope will help is a lot of analysis of those trial endpoints and hopefully a lot of academic publications with a lot of transparency about exactly what happened in those endpoints so that the field can learn from it I don't think the approval teaches us that much although Ii'd have to say now that the FDA has approved two biologics for lupus it feels to me as though the approval pathway is that little bit more solid for future agents and so we're hopeful that that's the case.

How will we use the drug, i think--  we still don't know uh in rheumatoid arthritis a comparative disease everybody sort of knows what the graphs in a trial look like for a drug that works and we've got a lot of drugs that work and so we're used to understanding that a drug that passes that ACR20, 50, 70 threshold is a drug that works for our patients and then we use it and see. I don't think we know that yet for these BCLA and SRI endpoints how does that really translate to the clinic, I think we'll have to see it in our own patients and see and what I hope is that just like was done in the RA space there's a lot of energy and investment in follow-up studies-- treatment strategy studies treat-to-target studies etc to really understand where it sits for example should it be used only in patients who've failed everything else, or alternatively should it be used early in order to prevent complications and avoid the need for those other immunosuppressive drugs and steroids. Honestly we don't know the answer and further studies will be needed and that's what we hope for.

About the expert

Eric Morand

Professor Eric Morand is Head of the School of Clinical Sciences at Monash Health, Monash University's largest clinical school, and Head of the Monash Health Rheumatology Unit in Melbourne, Australia. Disclosures

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