FDA extends review of oral MS drug BG-12

Discuss Tecfidera (BG-12, dimethyl fumarate) as an oral treatment for multiple sclerosis.

FDA extends review of oral MS drug BG-12

Postby MSUK » Thu Oct 18, 2012 11:03 am

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Biotechnology company Biogen Idec Inc said U.S. health regulators extended by three months the review date of its much-awaited multiple sclerosis (MS) drug BG-12, but analysts said the delay was only a minor setback.

Shares of Biogen were down 2 percent at $150.72 in morning trading on the Nasdaq.

The stock has risen more than 50 percent over the past 12 months, largely on optimism about BG-12, which showed robust results in trials and had no safety concerns.

Analysts said the delay would push the review date to March, but added such extensions were not uncommon.

"The registrational studies for BG-12 - DEFINE and CONFIRM - enrolled about 1,200 and 1,400 patients, respectively. Given the size and complexity of the filings, we are not surprised that the FDA would require additional time to review the application," Barclays Capital analyst Anthony Butler said.

The U.S. Food and Drug Administration said it needed additional time to review the application, but did not ask for additional studies, according to Biogen.... Read More - http://www.msrc.co.uk/index.cfm/fuseact ... ageid/1679
MS-UK - http://www.ms-uk.org/
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Re: FDA extends review of oral MS drug BG-12

Postby stillfighting » Fri Oct 19, 2012 11:15 am

I find it strange they would do this to a drug with a good safety profile. They should come back and black box Gilenya.
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Re: FDA extends review of oral MS drug BG-12

Postby HarryZ » Fri Oct 19, 2012 11:37 am

It's not surprising that this has happened. After the debacle with Tysabri's initial approval, the FDA is being far more cautious in approving these very powerful drugs. Unfortunately, MS patients who were told by their docs that this drug would be available later this year, are going to have to wait in their decision making.

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