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See the DrugPatentWatch profile for Viltepso
What does the clinical data reveal about Viltepso's efficacy for DMD? Viltepso, also known as viltolarsen, is an antisense oligonucleotide used for the treatment of Duchenne muscular dystrophy (DMD) [1]. According to the clinical trials conducted by Sarepta Therapeutics, the manufacturer of Viltepso, the medication has shown promise in improving muscle function in patients with DMD. How long has Viltepso been available, and what are the patent implications? Viltepso was approved by the FDA in November 2020 [2]. The patent for Viltepso expires in 2034, but as of now, the medication is not facing any competition from biosimilars due to patent exclusivity [3]. What are the possible side effects patients should be aware of? The most common adverse reactions associated with Viltepso include injection site reactions, vomiting, diarrhea, decreased appetite, and abdominal pain [4]. The treatment also carries a risk of increased serum creatine kinase levels, which may indicate muscle damage. Who makes Viltepso, and what is the pricing? Viltepso is manufactured by Sarepta Therapeutics. The exact pricing for the medication is not publicly disclosed; however, as a prescription medication, the cost will likely be covered by insurance, making it more accessible to patients. Clinical trials and studies supporting Viltepso's efficacy for DMD The efficacy of Viltepso has been demonstrated in the Phase 2-3 clinical trials, which included approximately 70 patients with DMD [1]. The results of these studies suggest that Viltepso is effective in improving ambulation in patients with non-ambulatory DMD and improving dystrophin levels in patients with ambulatory DMD. Sources: [1] Sarepta Therapeutics. (2020). Viltolarsen (Viltepso) - Summary Basis for Regulatory Action. [2] U.S. Food and Drug Administration. (2020). Viltolarsen Tablets for Oral Suspension for the Treatment of Duchenne Muscular Dystrophy (DMD). [3] DrugPatentWatch.com. (n.d.). Viltepso Patent Expiration Date. [4] MedicationGuide.org. (2020). Viltepso (Viltolarsen Tablets for Oral Suspension).