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FDA Approves New Tx for gMG – Zilbrysq

…..catching up on FDA Approvals

The FDA has approved a new subcutaneous therapy, Zilbrysq (zilucoplan) from UCB, for the treatment of adults with generalized myasthenia gravis.  Zilbrysq is the first once-daily subcutaneous, targeted C5 complement inhibitor for gMG. It is the only once-daily gMG-target therapy for self-administration.

gMG is a rare autoimmune disease with a global prevalence of 100–350 cases per every 1 million people. Symptoms of the disease include severe muscular weakness, drooping eyelids, difficulty with swallowing, chewing and talking, as well as life-threatening weakness of the respiratory muscles.

Zilbrysq was approved with a Black Box Warning for serious meningococcal infections.

CLICK HERE to access prescribing information 

UCB has not yet confirmed pricing for Zilbrysq.

Given that Zilbrysq is a self-administered, sub-q therapy with a Black Box Warning, it is expected that it will be channeled through specialty pharmacy limited distribution.

CLICK HERE to access the full UCB press release

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