Roche Holding AG

06/15/2021 | Press release | Distributed by Public on 06/14/2021 23:03

Roche data at EAN 2021 showcase significant impact of therapies across diverse neuroscience portfolio

Basel, 15 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced that data across its growing neuroscience portfolio will be presented at the 7th Congress of the European Academy of Neurology (EAN) Annual Meeting being held virtually 19-22 June, 2021. These new and encore data demonstrate Roche's commitment to advancing the clinical understanding of a broad range of neurological disorders with the goal of meeting the needs of people living with both the rarest and most common conditions.'

Our data at EAN and recent European regulatory milestones for EVRYSDI and ENSPRYNG reflect our continued commitment to discovering and developing breakthrough medicines for challenging neurological conditions.' said Levi Garraway, M.D., Ph.D., Roche's Chief Medical Officer and Head of Global Product Development. 'We are honoured to work with our partners and the broader community to accelerate progress across our neuroscience portfolio with the goal of transforming the lives of many people living with neurological disorders.'

Spinal Muscular Atrophy (SMA)
Roche will present updated data from across the extensive EVRYSDI™ (risdiplam) clinical development programme, designed to represent a broad spectrum of people living with SMA, including those who have previously been treated with another SMA medication.

Among the five abstracts featured, new data includes 12-month safety, pharmacodynamic and interim exploratory efficacy data from the JEWELFISH study of EVRYSDI in people previously treated with SMA-targeting therapies across a broad range of ages (1-60 years), SMA types (1-3) and SMN2 copy number (1-5).

Data from SUNFISH Part 2 supporting the safety profile and efficacy of EVRYSDI in people aged 2-25 years with SMA Types 2 or non-ambulant Type 3 after two years of treatment will also be shared, as well as updated 2-year safety and efficacy data from the pivotal FIREFISH Parts 1 and 2 showing continued improvements in survival and motor milestones in infants aged one to seven months with Type 1 SMA.

In addition, preliminary safety and efficacy data from the RAINBOWFISH study of EVRYSDI treatment in pre-symptomatic babies from birth to six weeks will be presented, along with longer-term safety data from a separate pooled analysis of the FIREFISH, SUNFISH, JEWELFISH and RAINBOWFISH trials.

EVRYSDI, the first and only at home SMA treatment, is now approved in 42 countries, including the U.S. and EU. More than 3,000 patients have been treated with EVRYSDI in clinical trials, compassionate use and real-world settings.