Biogen Idec Inc. : US and EU Regulatory Authorities Accept Oral BG-12 Marketing Applications for Review
05/09/2012| 04:10pm US/Eastern
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Today Biogen
Idec (NASDAQ: BIIB) announced that U.S. and EU regulatory
authorities have accepted the company's marketing applications for the
review of BG-12 (dimethyl fumarate), an oral therapeutic candidate for
the treatment of multiple sclerosis (MS). The U.S. Food and Drug
Administration (FDA) has accepted Biogen Idec's New Drug Application
(NDA) for marketing approval of BG-12 in the United States and granted
the company a standard review timeline. In addition, the European
Medicines Agency (EMA) has validated Biogen Idec's Marketing
Authorisation Application (MAA) for review of BG-12 in the European
Union.
Biogen Idec's regulatory applications for BG-12 were based on a
comprehensive clinical development program in which BG-12 demonstrated
significant reductions in MS disease activity coupled with favorable
safety and tolerability in two pivotal Phase 3 clinical trials. Biogen
Idec announced that it submitted an NDA to the FDA and an MAA to the EMA
in the first quarter of 2012. The company also recently submitted
regulatory applications in Canada and Switzerland.
About BG-12
BG-12 (dimethyl fumarate) is an investigational oral therapy under
regulatory review for the treatment of MS. BG-12 is the only currently
known investigational compound for the treatment of MS that has
experimentally demonstrated activation of the Nrf-2 pathway. In 2011,
Biogen Idec announced positive data from DEFINE and CONFIRM, two global,
placebo-controlled Phase 3 clinical trials that evaluated 240 mg of
BG-12, administered either twice a day or three times a day, for two
years. BG-12 is currently being evaluated in a long-term extension
study, ENDORSE.
About Biogen Idec
Through cutting-edge science and medicine, Biogen Idec discovers,
develops and delivers to patients worldwide innovative therapies for the
treatment of neurodegenerative diseases, hemophilia and autoimmune
disorders. Founded in 1978, Biogen Idec is the world's oldest
independent biotechnology company. Patients worldwide benefit from its
leading multiple sclerosis therapies, and the company generates more
than $5 billion in annual revenues. For product labeling, press releases
and additional information about the company, please visit www.biogenidec.com.
MEDIA CONTACT:
Biogen Idec
Kate Niazi-Sai,
+1-781-464-3260
or
INVESTOR CONTACT:
Biogen Idec
Benjamin
Strain, +1-781-464-2442
© Business Wire 2012
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