Advertise With UsAdvertise on our extensive network of industry websites and newsletters.
Get the PBR newsletterSign up to our free email to get all the latest PBR
news.Roche has said that the European Commission has approved RoACTEMRA to treat patients with rheumatoid arthritis.
Subscribe to our email newsletter
RoACTEMRA, in combination with methotrexate (MTX), is indicated for the treatment of adult patients with moderate to severe rheumatoid arthritis (RA) who have either responded inadequately to, or who were intolerant to, previous therapy with one or more disease modifying anti-rheumatic drugs (DMARDs) or tumour necrosis factor antagonists.
In these patients, RoACTEMRA can be given as monotherapy in cases of intolerance to MTX or where continued treatment with MTX is inappropriate. RoACTEMRA is said to be the first interleukin-6 (IL-6) receptor-inhibiting monoclonal antibody developed for the treatment of RA and is a novel approach to help tackle this debilitating disease.
The approval in the EU follows earlier approvals for the product in several countries, including Japan, India and Switzerland.
William Burns, CEO of Roche’s pharmaceuticals division, said: “The approval of RoACTEMRA offers new hope for patients suffering from the debilitating effects of rheumatoid arthritis. Roche will work with the authorities in EU member countries to ensure that this groundbreaking therapy will be available to patients as quickly as possible.”