Long-term interim clinical trial data for injection of VILTEPSO® (viltolarsen) to be presented at World Muscle Society Virtual Conference 2021
PARAMUS, New Jersey, September 17, 2021 / PRNewswire / – NS Pharma, Inc. (NS Pharma; president, Tsugio Tanaka), a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. (Nippon Shinyaku; president, Toru Nakai), today announced an electronic poster presentation on the long-term efficacy and safety data (interim analysis at 109 weeks) of the open-label extension (up to 192 weeks) of a phase study 2 by VILTEPSOÂ® (viltolarsen) at the World Muscle Society 2021 Virtual Conference taking place September 20-24.
The electronic poster presentation will be given by Paula Clemens, MD of the University of Pittsburgh Medical school on Thursday 23 Septemberrd of 4:30 p.m. to 6:30 p.m. BST. For more information, please visit the World Muscle Society Virtual Conference website for the full program: https://www.wms2021.com/page/programme.
About VILTEPSOÂ® (viltolarsen) injection
Prior to its approval in the United States, 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 likely to skip exon 53 treatment. Prior to its approval in Japan, VILTEPSO has obtained the SAKIGAKE designation, the orphan drug designation and the conditional early approval system designation.
VILTEPSO is indicated for the treatment of Duchenne muscular dystrophy (DMD) in patients with a confirmed mutation in the DMD gene capable of skipping exon 53. This indication is approved under accelerated approval based on an increase in skeletal muscle production of dystrophin seen in patients treated with VILTEPSO. Continued approval for this indication may depend on verification and description of clinical benefit in a confirmatory trial.
Important safety information
In clinical studies, no patient experienced renal toxicity during treatment with VILTEPSO. However, kidney toxicity from drugs like VILTEPSO may be possible. Your doctor may monitor the health of your kidneys before you start and during treatment with VILTEPSO.
Common side effects include upper respiratory tract infection, injection site reaction, cough, and fever.
About NS Pharma, Inc.
NS Pharma, Inc., is a wholly owned subsidiary of Nippon Shinyaku Co., Ltd. For more information, please visit http://www.nspharma.com. NS Pharma is a registered trademark of the Nippon Shinyaku group of companies.
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SOURCE NS Pharma