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FDA approves Rituxan for rare diseases

The US FDA has approved Genentech's marketed cancer and arthritis drug Rituxan (rituximab) for two new indications aimed at treating rare diseases
The US Food and Drug Administration (FDA) has approved Genentech's marketed cancer and arthritis drug Rituxan (rituximab) for two new indications aimed at treating rare diseases. 

The blockbuster drug has been cleared for use in combination with steroids to treat patients with Wegener's granulomatosis (WG) and microscopic polyangiitis (MPA), disorders that cause blood vessel inflammation that can lead to tissue damage. WG mostly affects the respiratory tract and kidneys, while MPA commonly affects the kidneys, lungs, nerves, skin, and joints. Rituxan is the first approved treatment for the diseases. 

The approval for the two orphan indications was based on a single controlled trial, in which 197 patients with WG or MPA received either Rituxan plus glucocorticoids once a week for four weeks or oral cyclophosphamide plus glucocorticoids daily. After six months, 64 per cent of patients treated with Rituxan had complete remission compared to 53 per cent of patients treated with cyclophosphamide.  

Genentech will be required to conduct a postmarketing study to demonstrate long-term safety, as well as the safety of more than one course of the drug in patients with WG and MPA. 

Rituxan, an antibody that is manufactured through biotechnology methods, works by reducing a patient's number of B cells. The drug, which must injected by a healthcare professional, was originally approved by the FDA in 1997. It is indicated for the treatment of patients with non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. 

Separately, Genentech's parent company, Roche, announced FDA approval of its cobas HPV (Human Papillomavirus) test, which is designed to help doctors identify women at high risk of developing cervical cancer. 

The product "is the only FDA-approved cervical cancer screening test that allows HPV 16 and 18 genotyping concurrently with high-risk HPV testing," according to Roche. "It individually identifies genotypes 16 and 18, responsible for more than 70 per cent of cervical cancer cases, while simultaneously detecting 12 other high risk HPV genotypes."

21st April 2011

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