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Nexviazyme prescriptions are available at general hospitals
by Eo, Yun-Ho Jan 12, 2024 07:05am
Sanofi-Aventis Korea’s Nexviazyme (Avalglucosidase Alfa) Prescriptions for Pompe disease treatment ‘Nexviazyme’ will be available at general hospitals. According to the industry, Sanofi-Aventis Korea’s Nexviazyme (Avalglucosidase Alfa) has recently passed the Drug Committee (DC) of tertiary general hospitals, including Samsung Seoul Hospital, Seoul National University Hospital, Seoul Asan Hospital, Seoul St. Mary's Hospital, and Sinchon Severance Hospital, and other hospitals where Pompe disease treatment is possible. Nexviazyme, developed based on Sanofi’s enzyme replacement therapy ‘Myozyme (avalglucosidase alfa)’ with improvements in usage and dosage, has become the first biobetter to receive preferential drug pricing by the government. In 2016, the government made an announcement regarding preferential drug pricing system, including both biosimilars that demonstrated healthcare enhancements in Korea and biobetters that demonstrated improvements from previously approved biomedicines. According to the announcement, recognizing the challenges in developing biobetters compared to incrementally modified drugs (IMD, synthetic drugs), the pricing of biobetters was set at 100-120% of the pricing of their drug targets (original biological drugs). Utilizing glycoengineering techniques, Nexviazyme has increased the amount of M6P, an important factor in the drug's intracellular uptake, by approximately 15-fold compared to Myozyme. The higher amount of M6P leads to increased drug uptake and improved GAA activity, effectively reducing damage to muscle cells through efficient glycogen breakdown. Moreover, the increased surface M6P enhances immunogenicity, providing safety benefits Pompe disease is a hereditary neuromuscular disorder caused by a deficiency in the enzyme acid alpha-glucosidase (GAA), which is responsible for breaking down glycogen in the muscles. The condition is progressive and can affect individuals of all ages. Left untreated, it can lead to irreversible muscle damage, respiratory and motor function impairment, and even premature death. In the COMET and MINI-COMET studies, enrolling Pompe disease patients, treatment with Nexviazyme demonstrated a 2.43% improvement in forced vital capacity (FVC) compared to Myozyme, with the benefit persisting consistently for up to 97 weeks. In 6 minute-walk test, compared to Myozome, participants administered with Nexviazyme showed a mean distance increase of 30m (4.71%) and demonstrated improvements in the trial’s secondary objectives, including gross motor function, health-related quality of life, and others.