The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

Shots: The US FDA has approved Amgen's Uplizna for the treatment of AChR & MuSK antibody positive adults with generalized myasthenia gravis (gMG) Approval was based on P-III (MINT) trial in 238 adults with gMG (190 AChR+, 48 MuSK+), where pts received 2 Uplizna loading dose followed by 2 doses/year; pts on steroids began tapering…

ByRidhi RastogiDecember 12, 2025

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Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)

Shots: Amgen has reported P-III (MINT) trial data on Uplizna vs PBO in adults (N=238) with AChR+ gMG (n=190) or MuSK+ gMG (n=48), followed for 52 & 28wks., respectively; sBLA under FDA’s priority review for IgG4-RD (PDUFA: Apr 3, 2025), with regulatory filings expected to end by H1’25 Pts received an initial loading dose…

ByRidhi RastogiMarch 17, 2025

The US FDA Approves Amgen’s Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis

Amgen Reveals P-III (MINT) Study Data of Uplizna (Inebilizumab-cdon) to Treat Generalized Myasthenia Gravis (gMG)

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