Zilucoplan: First Approval

Author:

Shirley Matt

Publisher

Springer Science and Business Media LLC

Subject

Pharmacology (medical)

Reference19 articles.

1. US FDA. ZILBRYSQ (zilucoplan) injection, for subcutaneous use: US prescribing information. 2023. https://www.accessdata.fda.gov/drugsatfda_docs/label/2023/216834s000lbl.pdf. Accessed 10 Nov 2023.

2. Pharmaceuticals and Medical Devices Agency. ZILBRYSQ® syringe for SC injections: Japanese prescribing information. 2023. https://www.pmda.go.jp/english/review-services/reviews/approved-information/drugs/0003.html. Accessed 10 Nov 2023.

3. Howard JF Jr, Bresch S, Genge A, et al. Safety and efficacy of zilucoplan in patients with generalised myasthenia gravis (RAISE): a randomised, double-blind, placebo-controlled, phase 3 study. Lancet Neurol. 2023;22(5):395–406.

4. UCB. UCB announces approval of RYSTIGGO[®] (rozanolixizumab) and ZILBRYSQ[®] (zilucoplan) for the treatment of adult patients with generalized myasthenia gravis in Japan [media release]. 2023. https://www.ucb.com/stories-media/Press-Releases/article/UCB-announces-approval-of-RYSTIGGOR-rozanolixizumab-and-ZILBRYSQR-zilucoplan-for-the-treatment-of-adult-patients-with-generalized-myasthenia-gravis-in-Japan. Accessed 25 Sep 2023.

5. US FDA. Zilbrysq NDA approval. 2023. https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2023/216834Orig1s000ltr.pdf. Accessed 10 Nov 2023.

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