TNF-blockers continue to expand indications
pharmafile | May 14, 2004 | News story | |
Competitors in one of the industry's fastest growing markets, the TNF-blocker class of rheumatoid arthritis drugs, have gained extensions to their licences as competition intensifies.
Schering-Plough's Remicade is the market leader, with sales of $1.72 billion in 2003 and has now gained preliminary approval in Europe to treat patients at an earlier stage of the often crippling chronic, progressive disease.
The EU's CPMP has recommended the drug be licensed as a first-line therapy in combination with methotrexate or other disease-modifying drugs for the treatment of early rheumatoid arthritis patients with severe, active and progressive disease.
Paul Emery, clinical director, rheumatology, Leeds Teaching Hospital Trust said the results from the ASPIRE trial of the drug shows it can prevent the progression of the disease, adding: "The ASPIRE results contribute to the growing clinical evidence supporting earlier initiation of therapy for RA patients."
Meanwhile, Abbott's rival drug Humira is now set to gain an EU licence for use in combination with standard disease-modifying treatment methotrexate.
The EMEA based its decision on one study of RA patients whose disease was assessed by means of patient X-rays showing bone erosion and joint-space narrowing.
Abbott said that patients taking a combination of Humira and methotrexate saw less bone erosion and joint-space narrowing at six and 12 months than those who took methotrexate on its own.
Humira was approved last September in the EU as a second line treatment of moderate to severe, active RA in adult patients when the response to disease modifying anti-rheumatic drugs, including methotrexate, has been inadequate.
Humira is an important new product for Abbott and the label extension to its RA licence comes ahead of plans for a number of other indications for the drug. Further Humira clinical trials are progressing for early RA, juvenile RA, psoriasis, psoriatic arthritis, ankylosing spondylitis and Crohn's disease.
Enbrel, the second biggest-selling drug in the class has also received an extension to its licence, this time in the lucrative US market.
The FDA has approved the drug for the treatment of chronic moderate to severe plaque psoriasis patients who are candidates for systemic therapy or phototherapy.
Dermatologists are already familiar with the drug, the only approved treatment for psoriatic arthritis, with some already prescribing the drug off-label for plaque psoriasis.
The approval is the fifth disease indication for Enbrel in just over five years and will help co-marketers Amgen and Wyeth sustain its rapid growth in sales, which more than trebled in 2003.
