Abbott Laboratories has received approval from the European Commission to market Humira (adalimumab), previously known as D2E7, for the treatment of adult rheumatoid arthritis (RA) in Europe.
"We are excited about the European Union approval of Humira as it brings new hope to the approximately two-and-a-half million people in Europe who suffer from this debilitating condition," said Guillermo Herrera, senior vice president, International Operations, Abbott Laboratories.
Humira will be available at pharmacies in Germany and the United Kingdom within five days. Availability in other European Union (E.U.) countries will occur in subsequent months as each country adopts pricing and reimbursement policies. In recent months, the drug has been made available in Europe through patient named basis programs or clinical study protocols. Abbott filed for E.U. approval in April 2002 and received a positive opinion from the European Medicines Evaluation Agency (EMEA) in May 2003. Humira received approval from the U.S. Food and Drug Administration on December 31, 2002, and since then in nine additional countries. Also in May, as a result of the strong physician uptake and positive patient response in the U.S., Abbott raised the global sales expectations of Humira for this year from more than $200 million to more than $250 million.
The E.U. approval for HUMIRA was based on data obtained in four controlled clinical trials. In all, 23 trials have been conducted with Humira, involving more than 2,400 RA patients worldwide. The drug's effectiveness was evaluated by measuring patients' improvement in RA signs and symptoms response scores. Safety also was assessed in these trials, which included one of the largest prospective safety trials of a TNF-antagonist. Some patients in trials have been taking Humira for more than five years.
Humira is the first human monoclonal antibody available in Europefor RA, and the first tumor necrosis factor alpha (TNF-a) antagonist approved with an indication for use with methotrexate or as monotherapy. In the E.U., Humira is indicated for the treatment of moderate to severe active RA in adult patients when the response to disease modifying anti-rheumatic drugs (DMARDs), including methotrexate, has been inadequate. To ensure maximum efficacy, Humira is given in combination with methotrexate. Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.