FDA Panel Advises Approval Of Teva's Copaxone

The Peripheral and Central Nervous System Drugs Advisory Committee to the US Food and Drug Administration has recommended the approval of Israel-based Teva Pharmaceuticals' Copaxone (copolymer 1), for the treatment of relapsing-remitting multiple sclerosis.

Since Teva first filed a New Drug Application in June 1995, the company has had to overcome a number of hurdles in the approval process such as the announcement that the FDA was to postpone a ruling on marketing approval for Copaxone and would instead require the drug to go before an advisory committee (Marketletter July 29). An earlier delay in approval occurred when the product was not included on the agenda of a previous advisory panel meeting (Marketletter May 20).

Study Results The approval recommendation was based on two studies. The principal one, a 252-patient double-blind study, was conducted at the University of Maryland Medical Center and the University of Texas-Houston Health Science Center. Researchers found that patients who took Copaxone for two years demonstrated a 29% reduction in attacks, and that those who took the drug for up to 35 months had a 32% drop in attack rates. Patients also seemed to show improvement in their physical condition, but this data failed to convince panelists that the drug may be effective in retarding the progression of the disease, or in reversing its disabling effects. There were some adverse reactions to Copaxone, including chest tightness and flushing.