This article is part of the Arthritis Archives.
April 8, 2009 UPDATE: Genentech, Inc. has announced a phased voluntary withdrawal of the psoriasis drug Raptiva (efalizumab) from the U.S. market based on the association of Raptiva with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system. Raptiva is indicated for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or phototherapy.
Dateline: May 13, 2003
Development of Raptiva for RA Halted
Genentech Inc. and Xoma Ltd. have halted the development of Raptiva (efalizumab) which was to be the newest anti-TNF drug for rheumatoid arthritis. Genentech, hoping to tap into the lucrative market of drugs known as "biologics" made the decision to stop further testing of Raptiva for rheumatoid arthritis after a phase II trial of 240 patients did not result in any "net clinical benefit".
Currently, the FDA is reviewing the application to market Raptiva for the skin disorder psoriasis. The results are disappointing for Genentech and Xoma, two companies with a vision of competing with the new biologic rheumatoid arthritis drugs, three of which have been approved by the FDA in the past 4 years:
- Enbrel (etanercept)(Amgen Inc.)
- Remicade (infliximab)(Johnson & Johnson)
- Humira (adalimumab)(Abbott Laboratories Inc.)
Approximately 2 million Americans suffer from rheumatoid arthritis. The newest member of this class of drugs, Humira, was just FDA-approved in January 2003. In the first three months of the year, Humira sales totaled $26 million. With such encouraging sales results, which were above the projections of Wall Street analysts, Abbott anticipates sales of $200 million in 2003 for Humira and $500 million in 2004. Amgen's Enbrel and Johnson and Johnson's Remicade totaled nearly $2 billion in sales in 2002.
Biologic Drugs
The successful sales figures combined with the success of biologic drugs as a treatment option for rheumatoid arthritis cannot be overstated. The failure of Raptiva in phase II clinical testing seems a bigger blow to Xoma than Genentech. Genentech is also testing its cancer drug Rituxan for rheumatoid arthritis and will soon enter into phase III trials.
Editor note: On 03/01/2006, Rituxan was FDA approved to be used in combination with methotrexate to treat rheumatoid arthritis by reducing the signs and symptoms in adult patients who have moderately-to-severely active rheumatoid arthritis and have failed one or more anti-TNF drugs e.g. Enbrel (etanercept), Remicade (infliximab), or Humira (adalimumab) See: Rituxan Approved For Rheumatoid Arthritis - The Facts Of RituxanThe group of anti-TNF drugs also known as "biologics" target tumor necrosis factor, a protein in the body involved in the inflammation pathway. Since both rheumatoid arthritis and psoriasis are linked to proteins associated with inflammation researchers believe this group of drugs may benefit both. Amgen, Johnson and Johnson, and Abbott are also testing their biologics to treat psoriasis.
Related Resources
- Raptiva (Efalizumab)
- TNF Blockers / Biologic DMARDs
- Rheumatoid Arthritis
Sources: Genentech and XOMA Discontinue Rheumatoid Arthritis Trial, Genentech Press Release 5/12/2003; Genentech Arthritis Drug Fails Key Test, Associated Press, 5/13/2003; Genentech, Xoma halt Raptiva arthritis testing, Reuters, 5/12/2003
First published: 5/13/2003
