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Application submitted to FDA for approval of Plegridy™
Posted: Tue May 21, 2013 5:26 am
by MSUK
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
Re: Application submitted to FDA for approval of Plegridy™
Posted: Tue May 21, 2013 4:22 pm
by CureOrBust
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.
Re: Application submitted to FDA for approval of Plegridy™
Posted: Wed May 22, 2013 2:45 am
by whyRwehere
On the radio today, they said it was an improvement on Biogen's "successful drug, Avonex." Didn't know whether to chuckle or sigh.
Re: Application submitted to FDA for approval of Plegridy™
Posted: Wed May 22, 2013 7:36 am
by HarryZ
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.
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.
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
Re: Application submitted to FDA for approval of Plegridy™
Posted: Wed May 22, 2013 7:55 am
by whyRwehere
Exactly....sigh.