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Roche recently announced new exploratory 2-year long-term data for the second part of the SUNFISH study.
Evrysdi is a liquid preparation that can be administered orally or via a feeding tube at home, once a day.
It is worth mentioning that Evrysdi is the first oral therapy for SMA and the first SMA therapy that can be administered at home.
In clinical trials, Evrysdi has shown clinically significant improvements in motor function in SMA patients of different ages and disease severity (including type 1, type 2, and type 3).
Eugenio Mercuri, MD, Ph.
The patients in the second part of the SUNFISH study were between 2-25 years old.
The survey results show that Evrysdi: (1) According to the measurement of the motor function measurement 32 scale (MFM-32), it maintains the improvement of motor function during 12-24 months.
Compared with the first year, there were fewer serious adverse events, high-level adverse events, and treatment-related adverse events observed in the two treatment groups in the second year.
Levi Garraway, MD, Roche’s Chief Medical Officer and Head of Global Product Development, said: “These encouraging results confirm that the efficacy and safety of Evrysdi in patients with type 2 and type 3 SMA can be maintained over time.
Evrysdi is an oral liquid.
As part of the collaboration with the SMA Foundation and PTC Therapeutics, Genentech led the clinical development of Evrysdi.
Currently, Roche is conducting 4 global multi-center clinical studies (SUNFISH[NCT02908685], FIREFISH[NCT02913482], JEWELFISH[NCT03032172], RAINBOWFISH[NCT03779334]) to evaluate all types of Evrysdi treatment (type 1, type 2, type 3) The efficacy and safety of SMA and presymptomatic SMA in neonates.
Spinraza: The world's first SMA treatment drug, approved in China
SMA is a motor neuron disease that can cause muscle weakness and atrophy.
In December 2016, Spinraza (nusinersen), a drug developed by Biogen and its partner Ionis, was approved and became the world's first drug for the treatment of SMA.
In May 2019, the gene therapy Zolgensma (onasemnogene abeparvovec) from Novartis was approved, becoming the world's first gene therapy to treat SMA.
In the Chinese market, Spinraza was approved at the end of February 2019 for the treatment of patients with 5q spinal muscular atrophy (5q-SMA).
Original Source: New 2-Year Data Show Genentech's Evrysdi (risdiplam) Continues to Demonstrate Improvement or Maintenance of Motor Function in People Aged 2-25 With Type 2 or Type 3 Spinal Muscular Atrophy (SMA)
