Friday, 29/08/2008
HUMIRA®
| Partners | Product | Target | Disease | PreC | PhI | PhII | PhIII | Fld | Mkt |
|---|---|---|---|---|---|---|---|---|---|
| Abbott | HUMIRA® | TNFα | rheumatoid arthritis | ||||||
| Abbott | HUMIRA® | TNFα | early rheumatoid arthritis | ||||||
| Abbott | HUMIRA® | TNFα | psoriatic arthritis | ||||||
| Abbott | HUMIRA® | TNFα | ankylosing spondylitis | ||||||
| Abbott | HUMIRA® | TNFα | Crohn's disease | ||||||
| Abbott | HUMIRA® | TNFα | juvenile rheumatoid arthritis | ||||||
| Abbott | HUMIRA® | TNFα | chronic plaque psoriasis | ||||||
| Abbott | HUMIRA® | TNFα | ulcerative colitis |
HUMIRA® (adalimumab) is a CAT-derived human anti-TNFα monoclonal antibody, isolated and optimised in collaboration with Abbott.
TNFα or Tumour Necrosis Factor Alpha is a protein produced by cells of the immune system that leads to inflammation and tissue damage and which is primarily responsible for inflammation, damage and destruction of the joints in rheumatoid arthritis. HUMIRA has been developed to neutralise TNFα and to both reduce inflammation pain and swelling of the joints and to prevent or slow long-term joint destruction in the treatment of rheumatoid arthritis.
HUMIRA has now been approved and marketed as a treatment for rheumatoid arthritis in over 50 countries. In January 2007, Abbott reported worldwide sales in 2006 of over US$2 billion. HUMIRA was the first product originating in the UK biotechnology industry to achieve 'blockbuster' status in 2005 (sales over US$1 billion). Worldwide sales of HUMIRA in 2007 totalled US$3 billion.
Abbott has received further approval from the Food and Drug Administration (FDA) and the European Agency for the Evaluation of Medicinal Products (EMEA) to market HUMIRA in additional indications.
- early rheumatoid arthritis - European approval August 2005
- psoriatic arthritis - European approval August 2005; US approval October 2005
- anklosing spondylitis - European approval June 2006; US approval July 2006
- Crohn's disease - US approval February 2007; European approval April 2007
In April 2007, Abbott submitted a Biologics License Application (BLA) with the FDA and EMEA for the treatment of chronic plaque psoriasis and for juvenile rheumatoid arthritis in May 2007.
Abbott has responsibility for undertaking all clinical trials of HUMIRA.
For further information, please visit http://www.humira.com