MabThera approved for rheumatoid arthritis
pharmafile | July 11, 2006 | News story | Sales and Marketing |
Roche's blockbuster cancer drug MabThera has gained European marketing approval to treat rheumatoid arthritis.
First launched in 1997, MabThera (rituximab) made its name as a treatment for non-Hodgkin's lymphoma, a cancer of the lymph nodes, and has become Roche's biggest selling product.
MabThera, (also marketed as Rituxan in the US) saw sales rise 23% in 2005 to $2.58 billion and it is now set to increase this rate of growth thanks to the new indication for rheumatoid arthritis.
While non-Hodgkin's lymphoma and rheumatoid arthritis may appear to be very different diseases, what they have in common is the role played by white blood cells called B-cells.
The cells play a key role in both diseases and MabThera works by stimulating the body's immune system to target them.
In non-Hodgkin's Lymphoma, the drug works by targeting and killing healthy and malignant B-cells, and then allows healthy B-cells to be regenerated.
In rheumatoid arthritis, MabThera prevents the B cells starting a chain-reaction, autoimmune process which ultimately leads to the cartilage loss and bone erosion that is characteristic of the disease.
MabThera is entering a market dominated by a new class of treatments for rheumatoid arthritis, the TNF-blockers, and has gained a licence for use in patients who have not responded or are intolerant to these drugs.
Roche says as many as 40% of patients given a TNF-blocker (such as Wyeth's Enbrel, Schering-Plough's Remicade, Abbott's Humira) do not have satisfactory outcomes, and says its drug offers a fundamentally different approach.
The drug is licensed in combination with methotrexate for patients who have failed TNF-blocker therapy, with clinical trials showing the drugs work together to stop further damage to joints caused by the disease.
"Due to the high number of patients who do not respond to or tolerate currently available therapies, there is a great need for novel and effective options", said William Burns, chief executive of Roche's pharmaceutical division.
"We are confident that MabThera, Roche's first innovative treatment for RA, will bring relief to patients with this debilitating disease and that our ongoing research and development programmes will yield more therapies for those who need them."
Rheumatoid arthritis is one of the most common forms of autoimmune disease and affects more than 21 million people worldwide, with as many as 3 million sufferers in Europe alone.
There are an estimated 387,000 sufferers of the disease in the UK, and Roche and its communications agency Red Door are now promoting the drug's new licence to the country's specialists.
MabThera has also just received a further licence in non-Hodgkin's lymphoma, allowing use of the drug as a maintenance treatment in patients with the indolent or slow-growing form of the disease.
