7.4 (Normosol-R pH 7.4). Caloric content, 21 kcal/L, Not specified in package insert. Labeled indications, Source of water and electrolytes. Alkalinizing agent
Viltepso [package insert]. Paramus, NJ: NS Pharma; 2020. The Food and Drug Administration (FDA) has granted accelerated approval to Viltepso (viltolarsen; NS Pharma) for the treatment of Duchenne
Viltolarsen was granted Priority Review … Affirm Upright Breast Biopsy System Package Inserts/IFUs. Aixplorer MultiWave Ultrasound System Package Inserts/IFUs. Amplified MTD Test. Analyte-Specific Reagents.
It is to be used only in patients who have a specific mutation of the dystrophin gene. About Viltepso Viltepso uses NS Pharma’s exon-skipping technology to target exon 53 of the DMD gene. Exon skipping is a treatment strategy in which sections of genetic code are “skipped” (spliced out, or left out) during the protein manufacturing process, allowing cells to create shortened but partially functional dystrophin protein, the muscle protein missing in DMD. Administration (FDA) has approved VILTEPSO™ (viltolarsen) injection for patients with Duchenne muscular dystrophy (DMD) who are amenable to exon 53 skipping therapy. VILTEPSO received an Accelerated Approval by the FDA based on an increase in dystrophin, a key protein for supporting muscle health. Since a lack of dystrophin is the FDA has granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation of the DMD gene that is amenable Viltolarsen (Viltepso ® in Japan) is a phosphorodiamidate morpholino antisense oligonucleotide being developed by Nippon Shinyaku, in collaboration with the National Center of Neurology and Psychiatry (NCNP), for the treatment of Duchenne muscular dystrophy (DMD). Viltepso (viltolarsen) is a medication used for the treatment of Duchenne muscular dystrophy (DMD) with a confirmed deficiency of the dystrophin gene amenable to exon 53 skipping therapy.
In March 2020 , VILTEPSO was approved in Japan for the treatment of patients with DMD who are amenable to exon 53 skipping therapy.
VILTEPSO™ is designed to skip exon 53 in the dystrophin gene. Status. VILTEPSO™ is an antisense oligonucleotide 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 (FDA label document).
VI. Coverage Renewal Criteria . Coverage can be renewed in up to 6-month intervals based upon the following: • Updated documentation (recent progress notes documenting overall disease status and ambulatory Medscape - Duchenne muscular dystrophy dosing for Viltepso (viltolarsen), frequency-based adverse effects, comprehensive interactions, contraindications, pregnancy & lactation schedules, and cost information. Viltepso while maintaining optimal therapeutic outcomes.
2020-08-13
Company: NS Pharma, Inc. Treatment for: Duchenne Muscular Dystrophy.
VILTEPSO received an Accelerated Approval by the FDA based on an increase in dystrophin, a key protein for supporting muscle health. Since a lack of dystrophin is the
FDA has granted accelerated approval to Viltepso (viltolarsen) injection for the treatment of Duchenne muscular dystrophy in patients who have a confirmed mutation of the DMD gene that is amenable
Viltolarsen (Viltepso ® in Japan) is a phosphorodiamidate morpholino antisense oligonucleotide being developed by Nippon Shinyaku, in collaboration with the National Center of Neurology and Psychiatry (NCNP), for the treatment of Duchenne muscular dystrophy (DMD). Viltepso (viltolarsen) is a medication used for the treatment of Duchenne muscular dystrophy (DMD) with a confirmed deficiency of the dystrophin gene amenable to exon 53 skipping therapy.
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Viltepso is approved in Japan under the name Viltolarsen (NS-065/NCNP-01).
NDC: • Viltepso 250 mg/5 mL single-dose vial: 73292-0011-xx VII. References 1. Viltepso [package insert]. Paramus, NJ; NS Pharma, Inc
Viltepso (viltolarsen) injection is a sterile, preservative-free, aqueous solution for intravenous administration.
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1. Viltepso [package insert]. Paramus, NJ: NS Pharma, Inc.; August 2020. 2. 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 (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. The mean values printed in this insert were derived from replicate analyses and are specific for this lot of product.