Roche wins expanded EU approvals for Gazyvaro, Actemra
Roche received expanded European approvals for its Actemra medication in giant cell arteritis (GCA) and for Gazyvaro in people with previously untreated advanced follicular lymphoma.
The medicines have been approved in other settings for years, but Roche is pushing to expand or accelerate their use as the Swiss company’s three main medicines, Avastin, Rituxan and Herceptin, with $20 billion in annual sales, come under threat of increasing competition from cheaper biosimilar copies. In 2016, sales of Actemra rose 16 per cent to 1.7 billion Swiss francs ($1.76 billion) for patients with rheumatoid arthritis but are due to more than double between now and 2024.
Gazyvaro, a blood cancer medicine Roche developed to follow its blockbuster Rituxan that this year lost patent protection, rose 52 per cent to 196 million francs last year. While Gazyvaro has been approved in Europe to treat follicular lymphoma as a secondline therapy in cases where Rituxan failed, clearing this latest regulatory hurdle allows Roche to deploy the medicine as a first-line therapy for patients just diagnosed with the most common form of nonHodgkin lymphoma.