2020-08-13 · PARAMUS, N.J., Aug. 12, 2020 /PRNewswire/ — NS Pharma, Inc. (NS Pharma; President, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; President Shigenobu Maekawa), announced today that the U.S. Food & Drug Administration (FDA) has approved VILTEPSO™ (viltolarsen) injection for patients with Duchenne muscular dystrophy (DMD) who are amenable to …

2020-08-12

80 mg/kg IV qWeek. VILTEPSO (viltolarsen) for the Treatment of Duchenne Muscular Dystrophy (DMD) VILTEPSO™ (viltolarsen) is an antisense oligonucleotide drug indicated to treat Duchenne muscular dystrophy (DMD), a rare genetic disorder, in patients with a confirmed DMD gene mutation that is vulnerable to exon 53 skipping therapy. The use of viltolarsen (Viltepso) for Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 53 skipping does not meet the definition of medical necessity, defined as delivery of a service by a … VILTEPSO and 88% of patients (7/8) showed dystrophin levels of 3% or greater than normal. Overall, after 20-24 weeks of treatment a mean increase in dystrophin expression to nearly 6% of normal was observed with VILTEPSO (80 mg/kg/wk) versus 0.6% at baseline. The most common side effects of VILTEPSO included upper respiratory tract infection, About VILTEPSO™ (viltolarsen) injection Prior to its approval in the U.S., VILTEPSO was granted Priority Review as well as Rare Pediatric Disease, Orphan Drug and Fast Track Designations.

Viltepso package insert

2019-10-05 · Provide the name of the drug and title of the package insert in italics. Type the full name of the drug followed by a colon. Then type the title of the package insert as stated at the top of the insert. Type the title in sentence-case, capitalizing only the first word and any proper nouns. Place a period at the end of the title. About GoodRx Prices and Viltepso Coupons GoodRx‘s cash prices are based on multiple sources, including published price lists, purchases, claims records, and data provided by pharmacies.

If the volume of VILTEPSO required is 100 mL or more, dilution is not required, and the .

About VILTEPSO™ (viltolarsen) injection Prior to its approval in the U.S., VILTEPSO was granted Priority Review as well as Rare Pediatric Disease, Orphan Drug and Fast Track Designations. In March 2020 , VILTEPSO was approved in Japan for the treatment of patients with DMD who are amenable to exon 53 skipping therapy.

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™ 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).

Viltepso 250 mg/5 mL single-dose vial: 73292-0011-xx VII. References 1. Viltepso [package insert]. Paramus, NJ; NS Pharma, Inc.; August 2020. Accessed August 2020. 2. Topaloglu H, Gloss D, Moxley RT 3rd, et al. Practice guideline update summary: Corticosteroid treatment of Duchenne muscular dystrophy: Report of the Guideline

Se hela listan på musculardystrophynews.com 8.2 8.5 11 12.1 12.2 13 13.1 16.1 HIGHLIGHTS OF PRESCRIBING INFORMATION These highlights do not include all the information needed to use About VILTEPSO™ (viltolarsen) injection. Prior to its approval in the U.S., VILTEPSO was granted Priority Review as well as Rare Pediatric Disease, Orphan Drug and Fast Track Designations. In March 2020, VILTEPSO was approved in Japan for the treatment of patients with DMD who are amenable to exon 53 skipping therapy. Document Library A single point-of-access to technical documents for our entire portfolio of medical devices, assays, test kits and Healthcare IT offerings. 2020-08-13 · The U.S. Food and Drug Administration (FDA) has conditionally approved NS Pharma ‘s Viltepso ( viltolarsen) for people with Duchenne muscular dystrophy (DMD) amenable to exon 53 skipping. Viltepso is given via intravenous (into-the-vein) administration at a dose of 80 mg/kg of body weight.

Viltepso [package insert]. Paramus, NJ: NS Pharma,. Inc.; 2020.
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1. Drug Points, and package insert) as defined in the Social. Security Act Package Insert (PPI), or disease state specific standard of care Viltepso ( viltolarsen).

Overall, after 20-24 weeks of treatment a mean increase in dystrophin expression to nearly 6% of normal was observed with VILTEPSO (80 mg/kg/wk) versus 0.6% at baseline. The most common side effects of VILTEPSO included upper respiratory tract infection, About VILTEPSO™ (viltolarsen) injection Prior to its approval in the U.S., VILTEPSO was granted Priority Review as well as Rare Pediatric Disease, Orphan Drug and Fast Track Designations. 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.
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of . 3. 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. References Viltepso [Package Insert]. Paramus, NJ: NS Pharma, Inc.; August 2020.

4. Viltepo (viltolarsen) [package insert]. Paramus, NJ: NS Pharma, Inc.; August 2020. APPROVAL HISTORY December 8, 2020: Reviewed by Pharmacy & Therapeutics Committee. Subsequent endorsement date(s) and changes made: 1. February 9, 2021: No changes. Added information throughout the Medical Necessity Guidelines

FDA Approved: Yes (First approved August 12, 2020) Brand name: Viltepso. Generic name: viltolarsen. Dosage form: Injection. Company: NS Pharma, Inc. Treatment for: Duchenne Muscular Dystrophy. Viltepso (viltolarsen) is an antisense oliogonucleotide indicated for the treatment of Duchenne muscular dystrophy (DMD) in VILTEPSO is a drug for the treatment of a particular type of Duchenne muscular dystrophy (DMD).

2020-08-13 · The US Food and Drug Administration granted accelerated approval to Viltepso (viltolarsen) injection 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. VILTEPSO prescription and dosage sizes information for physicians and healthcare professionals.