Lära Sig Dessa Yasui O To Ku — Viltepso Package Insert
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Viltepso is a clear and colorless solution. Viltepso is supplied in single-dose vials containing 250 mg/5 mL viltolarsen (50 mg/mL) in 0.9% sodium chloride. VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients amenable to exon 53 skipping. Accelerated approval is based on an increase in dystrophin. There is an ongoing study to confirm the clinical benefit of VILTEPSO.
In March 2020, VILTEPSO was approved in Japan for the treatment of patients with DMD who are amenable to exon 53 skipping therapy. VILTEPSO (viltolarsen) injection is a sterile, preservative-free, aqueous solution for intravenous administration. VILTEPSO is a clear and colorless solution. VILTEPSO is supplied in single-dose vials containing 250 mg/5 mL viltolarsen (50 mg/mL) in 0.9% sodium chloride. 2020-08-12 Viltepso [package insert]. Paramus, NJ: NS Pharma; 2020.
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Watanabe N, Nagata T, Satou Y, et al. NS-065/NCNP-01: An Antisense Oligonucleotide for Potential Treatment of Exon 53 Skipping in Duchenne Muscular Dystrophy. Mol Ther Nucleic Acids. 2018;13:442– 449. doi:10.1016/j.omtn.2018.09.017 VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO.
2018;13:442– 449. doi:10.1016/j.omtn.2018.09.017
VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping. This indication is approved under accelerated approval based on an increase in dystrophin production in skeletal muscle observed in patients treated with VILTEPSO. 2021-03-01 · Viltepso (viltolarsen) injection is a sterile, preservative-free, aqueous solution for intravenous administration. Viltepso is a clear and colorless solution. Viltepso is supplied in single-dose vials containing 250 mg/5 mL viltolarsen (50 mg/mL) in 0.9% sodium chloride.
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Restricted Access – Do not disseminate or copy without approval. ©2020, Magellan Rx Management • J3490 – Unclassified drugs. NDC: • Viltepso 250 mg/5 mL single-dose vial: 73292-0011-xx VII. References 1.
Paramus, NJ: NS Pharma, Inc.; August 2020. APPROVAL HISTORY December 8, 2020: Reviewed by Pharmacy & Therapeutics Committee.
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Viltepso - Po Sic In Amien To Web
In March 2020 , VILTEPSO was approved in Japan for the treatment of patients with DMD who are amenable to exon 53 skipping therapy.