F. Hoffmann-La Roche Ltd: Roche's ENSPRYNG approved by European Commission as first and only at-home subcutaneous treatment for neuromyelitis optica spectrum disorder (NMOSD)

• ENSPRYNG is the first and only treatment approved for both adults and adolescents in the EU with AQP4-IgG seropositive NMOSD
• ENSPRYNG can be used as a monotherapy or in combination with immunosuppressive therapy to reduce relapses and prevent permanent disability
• In Phase III studies, ENSPRYNG significantly reduced the number and severity of relapses in people with AQP4-IgG seropositive NMOSD
  

Basel, 28 June 2021 - Roche (SIX: RO, ROG; OTCQX: RHHBY) announced today that the European Commission (EC) has approved ENSPRYNG (satralizumab) for the treatment of adults and adolescents from 12 years of age living with anti-aquaporin-4 antibody (AQP4-IgG) seropositive neuromyelitis optica spectrum disorder (NMOSD), as a monotherapy or in combination with immunosuppressive therapy (IST). ENSPRYNG is the first and only NMOSD treatment that is administered subcutaneously every four weeks, allowing home-dosing after appropriate training.

"An NMOSD relapse can be devastating, causing permanent neurological damage and disability that accumulates with subsequent relapses, which is why our goal is to prevent them," said Prof. Dr. Friedemann Paul, Professor of Clinical Neuroimmunology, Charité Universitätsmedizin Berlin. "With the approval of ENSPRYNG, we now have a treatment option with a favourable safety profile that significantly reduces relapses in AQP4-IgG seropositive adults and adolescents after their first NMOSD attack or in more advanced disease, either as a monotherapy or in combination with IST. Importantly, people with NMOSD now have the flexibility to administer treatment at home, which may alleviate the need to travel for hospital appointments."

The EC approval is supported by results from two Phase III studies, in which ENSPRYNG showed robust and sustained efficacy in reducing the risk of relapse in people with AQP4-IgG seropositive NMOSD. AQP4-IgG are present in around 70-80% of people with NMOSD, who tend to experience a more severe disease course compared to those not expressing AQP4-IgG antibodies.

"We thank the NMOSD community for their partnership and are delighted that ENSPRYNG will be available to people in the EU who until now had limited, accessible treatment options," said Levi Garraway, M.D., Ph.D., Chief Medical Officer and Head of Global Product Development. "Building on our growing scientific understanding of neuroimmunological conditions, we are confident ENSPRYNG can transform how people with NMOSD are treated by fitting into their day-to-day lives."

ENSPRYNG is the first and only approved medicine for NMOSD in the EU designed to bind to and block the interleukin-6 (IL-6) receptor, a central driver of the inflammation associated with NMOSD. The treatment was designed by Chugai, a member of the Roche Group, using novel recycling antibody technology. When compared to conventional antibodies, ENSPRYNG's recycling antibody technology enables the medicine to remain in the bloodstream for a longer period of time and bind repeatedly to its target (the IL-6 receptor) - maximally sustaining IL-6 suppression in a chronic disease like NMOSD and enabling subcutaneous dosing every four weeks.

Roche is working closely with reimbursement and health technology assessment bodies in EU member states to provide access to ENSPRYNG for people who may benefit from this treatment option as soon as possible.

About SAkuraStar and SAkuraSky in NMOSD
ENSPRYNG has been investigated in two pivotal Phase III studies in neuromyelitis optica spectrum disorder (NMOSD), with the primary endpoint of both studies being time to first protocol-defined relapse (PDR) adjudicated by an independent review committee in the double-blind period.

The Phase III SAkuraStar study evaluated the efficacy and safety of ENSPRYNG monotherapy administered to adults with NMOSD. In the anti-aquaporin-4 antibody (AQP4-IgG) seropositive subgroup, 83% treated with ENSPRYNG remained relapse free at 48 weeks, compared with 55% of those treated with placebo. At 96 weeks, 77% of those treated with ENSPRYNG remained relapse free, compared with 41% with placebo.

The Phase III SAkuraSky study evaluated the efficacy and safety of ENSPRYNG in combination with baseline immunosuppressive therapy in adults and adolescents with NMOSD. Overall, 92% of AQP4-IgG seropositive participants receiving ENSPRYNG in combination with IST remained relapse free at 48 and 96 weeks, compared with 60% and 53% with placebo, respectively.

ENSPRYNG showed a favourable safety and tolerability profile in the Phase III studies. The most common adverse reactions observed in the safety population were: headache, arthralgia, white blood cell count decrease, hyperlipidaemia and injection-related reactions.

About neuromyelitisoptica spectrum disorder

Dr. Nicolas Dunant Phone: [phone]	Patrick Barth Phone: [phone]
Dr. Daniel Grotzky Phone: [phone]	Karsten Kleine Phone: [phone]
Nina Mählitz Phone: [phone]	Nathalie Meetz Phone: [phone]
Dr. Barbara von Schnurbein Phone: [phone]

Roche Investor Relations
Dr. Karl Mahler Phone: [phone] e-mail: [e-mail] (mailto:[e-mail])	Jon Kaspar Bayard Phone: [phone] e-mail: [e-mail] (mailto:[e-mail])
Dr. Sabine Borngräber Phone: [phone] e-mail: [e-mail] (mailto:[e-mail])	Dr. Bruno Eschli Phone: [phone] e-mail: [e-mail] (mailto:[e-mail])
Dr. Birgit Masjost Phone: [phone] e-mail: [e-mail] (mailto:[e-mail])	Dr. Gerard Tobin Phone: [phone] e-mail: [e-mail] (mailto:[e-mail])
Investor Relations North America
Loren Kalm Phone: [phone] e-mail: [e-mail] (mailto:[e-mail])

Attachment

• 28062021_MR_Enspryng EC approval (https://ml-eu.globenewswire.com/Resource/Download/c7c0f620-20f6-440a-b8c0-291395330705)