Recent Approvals and Upcoming FDA Submissions in Rheumatic Diseases


Dr Nehad Soloman provides insight on recent approvals and upcoming FDA submissions in biosimilars, including for lupus nephritis, and how they may change the course of rheumatic disease management moving forward.

Nehad Soloman, MD: Recently there have been new developments and expansion of label in upadacitinib for treatment of ankylosing spondylitis as well as nr-axSpA. Additionally, there have been updated label changes in gout products, for example, Krystexxa® with the co-administration of immunomodulation to help mitigate risks of infusion reactions as well as improve longevity on drug. There are new drugs that have been approved for the treatment of lupus as well as lupus nephritis. It's an exciting time in rheumatology now where some of these diseases that have been long ignored or have not had a good armamentarium of treatments now are increasing in interest in research as well as coming to market.

It's very exciting. On the horizon in 2023, there's an expectation of multiple submissions to the FDA currently engaged in quite a few clinical trials. One of which is for lupus nephritis and an exciting product that targets interferon in the treatment of lupus nephritis. Additionally, there's an IL17 AF that is going to be submitted for approval as well as an IL17 infusible. As the landscape starts to change, there will be more available options for our patients, both Medicare-aged as well as younger. In addition to help treat our patients who are going to have more options as well. As I mentioned earlier, these long-ignored diseases, have now new hope and new light for us. As we continue on in the 21st century, the pipeline of biologics continues to emerge and newer mechanisms of action continue to emerge as well.

As we know, lupus nephritis is one of the more dangerous and life-threatening components of systemic lupus erythematosus. It is exciting to know that since the end of 2020, we've had a couple of more options as add-on therapies available to us for folks with class 3, class 4, class 5 lupus nephritis with rather favorable outcomes in terms of tapering of steroids rapidly thereby mitigating complications of long-term steroid use in addition improvement in proteinuria as well as improvement in hematuria and renal function. It continues to be exciting for us in the rheumatology space to be able to have yet another agent available to us in this fight against lupus nephritis.

Transcript Edited for Clarity

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