Biogen double checks safety of drugs after Tysabri
BOSTON, June 19 (Reuters) - Biogen Idec Inc. (BIIB.O: Quote, Profile, Research) is taking a closer look at its experimental drugs in development to make sure none have any safety problems that could come back to haunt it later, according to a senior executive.
The move follows the company's traumatic experience with its multiple sclerosis drug Tysabri, which was withdrawn in 2005 after it was linked with two cases of a potentially fatal brain disease.
Earlier this month U.S. regulators said Biogen and its partner Elan (ELN.I: Quote, Profile, Research) could return the drug to the market, albeit with a severe warning and a special distribution program known as a risk map designed to monitor patient safety.
"We have gone back to our scientists and said, 'Let's look a little harder and see what the adverse events might be,'" said Burt Adelman, Biogen's vice president of development, at a conference in Boston.
Adelman said the issue of safety in drug development is becoming much more important and safety monitoring programs are likely to become more common.
Until now, the drug development process for all companies has focused primarily on efficacy, Adelman said, with safety data emerging as a by-product of the clinical trials.
In future, new protocols need to be developed for collecting and analyzing safety data during the course of a clinical trial.
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