[blair77]

Marizomib receives orphan drug designation

by blair77 on Fri Feb 28, 2014 10:01 am

I see that marizomib has received orphan drug status by the FDA. I understand how this status is beneficial to the drug company ( I.e. no generics for 7 years) but does this status help how fast it is approved?

Press release:

https://myelomabeacon.org/pr/2014/02/27/marizomib-fda-orphan-drug-designation/

[Nancy Shamanna]

Re: Marizomib receives orphan drug designation

by Nancy Shamanna on Fri Feb 28, 2014 1:36 pm

This is so interesting! The Triphase Accelerator Corp., from Toronto, is partnering with Celgene with this research. The proteasome inhibitor is being derived from a marine obligate actinomycete. Actinomycetes are a type of filamentous or rod shaped bacteria in the phylum chlamydobacteria. This is marine biology research, helping in myeloma treatments! Marizomib is currently in phase 1 and phase 2 trials, and is being combined with other myeloma drugs too.

[Nancy Shamanna]

Re: Marizomib receives orphan drug designation

by Nancy Shamanna on Fri Feb 28, 2014 6:29 pm

Coincidentally today I just received an online petition from Myeloma Canada regarding the Canadian Orphan Drug Framework. Canada does not yet have an 'orphan drug' classification, and in this we lag behind some other countries, including the U.S. If you are Canadian, or are interested in petitioning our Health Minister regarding CODR, please look into the MC website and fill out the online petition. This framework has been at least three years in the planning, and it is set up now...just needs the Health Minister to approve it!

[Nancy Shamanna]

Re: Marizomib receives orphan drug designation

by Nancy Shamanna on Fri Feb 28, 2014 6:58 pm

Sorry to post again, but actually the online petition is at the 'Canadian Orphan Drug Regulatory Framework Petition' website.

I see from Obayan's post that today is the orphan disease day. That would explain why the petition and also the announcement about Marizomib came out today I guess. Best wishes to you, Obayan!