Application submitted to FDA for approval of Plegridy™

A board to discuss the Multiple Sclerosis modifying drug Plegridy
Post Reply
User avatar
MSUK
Family Elder
Posts: 2903
Joined: Wed Oct 14, 2009 2:00 pm
Contact:

Application submitted to FDA for approval of Plegridy™

Post 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
MS-UK - http://www.ms-uk.org/
User avatar
CureOrBust
Family Elder
Posts: 3374
Joined: Wed Jul 27, 2005 2:00 pm
Location: Sydney, Australia

Re: Application submitted to FDA for approval of Plegridy™

Post 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.
User avatar
whyRwehere
Family Elder
Posts: 917
Joined: Mon Oct 03, 2005 2:00 pm
Contact:

Re: Application submitted to FDA for approval of Plegridy™

Post 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.
User avatar
HarryZ
Family Elder
Posts: 2572
Joined: Tue May 25, 2004 2:00 pm
Location: London, ON, Canada
Contact:

Re: Application submitted to FDA for approval of Plegridy™

Post 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
User avatar
whyRwehere
Family Elder
Posts: 917
Joined: Mon Oct 03, 2005 2:00 pm
Contact:

Re: Application submitted to FDA for approval of Plegridy™

Post by whyRwehere »

Exactly....sigh.
Post Reply

Return to “Plegridy”