Application submitted to FDA for approval of Plegridy™ (peginterferon beta-1a) in multiple sclerosis
Biogen Idec has announced it has submitted a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for approval of Plegridy™ (peginterferon beta-1a), the company’s pegylated subcutaneous injectable candidate for relapsing forms of multiple sclerosis (RMS)...... Read More - http://www.ms-uk.org/index.cfm/PEGylatedinterferonbeta
Application submitted to FDA for approval of Plegridy™
Application submitted to FDA for approval of Plegridy™
MS-UK - http://www.ms-uk.org/
- CureOrBust
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Re: Application submitted to FDA for approval of Plegridy™
For info specifically what it is: http://www.businesswire.com/news/home/2 ... al-Phase-3
U100 is a proprietary recombinant human interferon beta-1b being developed as a new chemical entity. Produced utilizing an advanced processing technology, the liquid product formulation is virtually aggregate-free and human serum albumin-free (HSA-free), which may result in lower immune responses, potentially improving overall long-term clinical efficacy and improving the tolerability and safety for RRMS patients presently requiring therapy with interferon beta-1b.
NU100 is a proprietary recombinant human interferon beta-1b produced utilizing proprietary manufacturing process technology. It is being developed as a standalone molecule for the treatment of relapsing remitting multiple sclerosis (RRMS) and as a new molecular entity based on positive opinion from the European Medicines Agency and the Food and Drug Administration. Patients treated with currently marketed interferon beta-1b products have up to 40 percent neutralizing antibody prevalence after two years of treatment. NU100 is essentially aggregate-free compared to those products; therefore, it should result in lower immune responses, potentially improving overall long-term clinical efficacy and improving the tolerability and safety for RRMS patients presently requiring therapy with interferon beta-1b.
- whyRwehere
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Re: Application submitted to FDA for approval of Plegridy™
On the radio today, they said it was an improvement on Biogen's "successful drug, Avonex." Didn't know whether to chuckle or sigh.
- HarryZ
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Re: Application submitted to FDA for approval of Plegridy™
Depends how you look at what they mean by "successful". If you mean in beneficial to the bottom line for Biogen, then quite $ucce$$ful! If you mean successful in treating an MS patient...well, that's a whole new ball game.whyRwehere wrote:On the radio today, they said it was an improvement on Biogen's "successful drug, Avonex." Didn't know whether to chuckle or sigh.
With a slight tweak to the original drug and only once every 2 or 4 week injection, then one would hope the price would be significantly lower for the patient. Sorry, must have had a brain cramp with that line of thinking. A new patent exists so you can imagine what the cost will be on this one!
Harry
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Re: Application submitted to FDA for approval of Plegridy™
Exactly....sigh.