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Roche's Actemra/RoActemra receives new European approval

EU regulators also pass the Swiss pharma firm’s Gazyvaro


Roche is celebrating two new approvals in the EU, including Actemra/RoActemra (tocilizumab), which becomes the first therapy approved in Europe to treat giant cell arthritis (GCA).

GCA is a chronic and potentially life-threatening autoimmune condition and Actemra/RoActemra’s approval was based on data from the phase III GiACTA study.

This showed that a weekly dose of Actemra/RoActemra, initially combined with a six-month steroid taper, significantly increased the proportion of patients achieving sustained remission at one year (56%) versus a steroid taper alone (14%).

Sandra Horning, chief medical officer and global head of production development, Roche, said: “We are delighted that Actemra/RoActemra has been approved for the treatment of GCA in Europe.

“As the first effective non-steroid therapy for GCA, Actemra/RoActemra has the potential to fundamentally change how this condition is treated.”

The biologic treatment is available as an intravenous or subcutaneous injection, which targets the interleukin-6 (IL-6) signalling pathway.

Gazyvaro approved for advanced follicular lymphoma

Meanwhile, the European Commission has also licensed Roche’s Gazyvaro (obinutuzumab) for patients with previously untreated advanced follicular lymphoma.

The treatment, which will be used in combination with chemotherapy, was approved based on the results of the phase III GALLIUM study, which showed superior progression-free survival over the biotech’s current standard of care MabThera (rituximab).

Horning said: “By challenging our own MabThera medicine head-to-head, we have been able to set a new standard of care for people with follicular lymphoma.

“Every year an estimated 19,000 people in Europe are diagnosed with the disease, which is considered to be incurable.

“We are pleased that with the approval of Gazyvaro, these patients now have an improved initial treatment option available to them.”

The biotech’s monoclonal antibody is doing well in the EU, racking up three approvals in just four years.

Its first approval was in combination with chlorambucil in 2014 to treat patients with previously untreated chronic lymphocytic leukaemia, and then the drug was given a second go-ahead for patients with follicular lymphoma who did not respond to or who progressed during or up to six months after treatment with a MabThera-containing regimen.

Article by
Gemma Jones

25th September 2017

From: Regulatory



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