Biogen Idec: focus on safety as well as efficacy needed

Biogen Idec’s executive vice-president for development, Burt Adelman, has said that the pharmaceutical industry must take a more careful approach to ensuring drug safety after concerns over one of his company’s drugs led to it being withdrawn temporarily.

Tysabri, a treatment for multiple sclerosis developed by Biogen Idec and Elan, was withdrawn last year after very rare cases of progressive multifocal leukoencephalopathy, a rare and fatal brain disease, were linked with drug’s use.

While more data was prepared for the drug, it was removed from marketing until last month, when it was granted a new licence with certain conditions and warnings attached to its use.

At a conference of researchers in Boston, Mr Adelman was quoted by Dow Jones Newswires as saying: “I used to say 51 per cent of drug development is safety. Now I say it should be 75 per cent.”

“We have to make sure we fully understand the mechanism of action that we’re dealing with, and what the potential upsides and downsides of that mechanism are. The industry tends to focus on the upsides,” he added.

Speaking of his company’s trouble with Tysabri, according to Reuters, Mr Adelman stated: “We have gone back to our scientists and said, ‘Let’s look a little harder and see what the adverse events might be.”

The drug’s re-approval was welcomed by MS Ireland, a charity that represents multiple sclerosis sufferers, which said the drug offered “great hope” to MS patients.

© Adfero Ltd