Roche is looking to get the go-ahead in Europe for its cancer drug MabThera to be marketed as a first-line treatment for rheumatoid arthritis.

The Swiss major says it has submitted a combined filing to the European Medicines Agency for MabThera (rituximab) in three new indications. Specifically, Roche wants the label on the biologic to be expanded to include first-line treatment for patients with RA who have not been treated with methotrexate, as well as for those who have had an inadequate response to the latter. Roche also wants the EMEA to approve MabThera for the prevention of joint damage for all patients with RA.

The submissions are based on the findings of three Phase III trials – IMAGE, SERENE and MIRROR – which revealed that combined treatment with MabThera and MTX improved the signs and symptoms of RA in patients, compared to those treated only with the latter drug. Roche also noted that findings from the IMAGE study demonstrated that combined therapy with MabThera and methotrexate can significantly reduce the progression of joint damage including a reduction in bone erosions, where areas of the bone are destroyed.

MabThera, which is marketed as Rituxan in the USA by Roche unit Genentech and Biogen Idec, is currently approved in Europe for patients with moderate-to-severe RA who are intolerant to, or who have not benefited from, treatment with one or more tumour necrosis factor inhibitors. Urs Schleuniger, head of inflammation/immunology at Roche, said that a “successful regulatory outcome will mean that clinicians and patients have a new treatment option to tackle the disease early on”. without experiencing the detrimental effects of RA and irreversible damage to their joints.

Meantime, Roche announced that it is withdrawing its acne drug Accutane (isotretinoin) from the US market.

The company has notified the US Food and Drug Administration that it is pulling Accutane after a reevaluation of its portfolio revealed that the drug faces serious generic competition. Also Roche “has been faced with high costs from personal-injury lawsuits that the company continues to defend vigorously,” the firm says.

The company has been hit by lawsuits which claim that Roche did not warn patients about potential links between Accutane and inflammatory bowel disease. The company said it still stands behind the safety of Accutane and the risk-management programmes it has developed.