FDA Grants Priority Review of sBLA for KRYSTEXXA and Methotrexate

Suneet Grewal, MD, a rheumatologist at East Bay Rheumatology Medical Group in the Bay Area discusses the supplemental Biologics License Application (sBLA) to expand the label KRYSTEXXA (pegloticase) plus methotrexate to treat uncontrolled gout and how this offers patients a substantially better chance of responding to therapy. The sBLA is based on the MIRROR randomized controlled trial (“Methotrexate to Increase Response Rates in Patients with Uncontrolled Gout Receiving KRYSTEXXA”) 

Suneet Grewal, M.D., is a rheumatologist at East Bay Rheumatology Medical Group in the Bay Area, CA. She received her medical degree from St. George’s University, completed her internal medicine residency at Alameda County Medical Center and rheumatology fellowship at Cedars-Sinai Medical Center. Dr Grewal has served as principal investigator of several clinical trials on gout and KRYSTEXXA, including the MIRROR and FORWARD randomized controlled trials.

Liked it? Take a second to support healthprofessionalradio on Patreon!

0 Comments

Leave a Reply

You must be logged in to post a comment.