CONTEXT: Another announcement on real world data supporting treatment for SMA. IT’s almost like another Swiss based pharmaceutical company made a similar announcement.
IMPACT: Medium
READ TIME: 5 mins
Quality Level Mean [1 – 10]: 8
1. “Basel, 16 March 2021 – Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced new exploratory 2-year longer-term data from Part 2 of SUNFISH, a global placebo-controlled study evaluating Evrysdi™ (risdiplam) in people aged 2-25 years with Type 2 or non-ambulant Type 3 spinal muscular atrophy (SMA).”
2. “Based on the natural history of the disease, people with Types 2 and 3 SMA who remain untreated decline in motor function over time.”
3. “Findings demonstrated that Evrysdi:. “These encouraging results confirm that the efficacy and safety of Evrysdi in people with Type 2 and Type 3 SMA can be sustained over time,” said Levi Garraway, M.D., Ph. D., Chief Medical Officer and Head of Global Product Development.”
4. “Roche leads the clinical development of Evrysdi as part of a collaboration with the SMA Foundation and PTC Therapeutics.”
5. “In April, the European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) recommended the approval of Evrysdi for the treatment of 5q SMA in patients 2 months of age and older, with a clinical diagnosis of SMA Type 1, Type 2 or Type 3 or with one to four SMN2 copies.”