|Dyax Gets FDA Breakthrough Therapy Designation for DX-2930|
|By Marilyn Mullen|
|Tuesday, 07 July 2015 15:06|
Dyax Corp. (NASDAQ:DYAX) has confirmed that U.S. Food and Drug Administration has given approval to Breakthrough Therapy designation for investigation of DX-2930 for hereditary angioedema.
The firm is developing an investigational fully human monoclonal antibody inhibitor DX-2930 of plasma kallikrein.
Breakthrough Therapy designation aims to fasten development as well as assess potential new medicines having early signs of clinical benefit in life-threatening conditions which aids in ensuring that patients gets access to them.
The treatment is thought of when preliminary clinical evidence shows that the drug may show significant improvement over available therapy.
On the other hand, the advantages of Breakthrough Therapy designation has organizational commitment including FDA’s senior managers.
This designation doesn’t alter standards for approval. It is additionally helped by results of Dyax’s Phase 1b clinical trial of DX-2930 in HAE patients.
The study of Phase 1b has completed all the aims including assessment of safety, tolerability as well as pharmacokinetics of a number of subcutaneous administrations of DX-2930.
Besides this, a pre-specified proof-of-concept efficacy analysis has shown huge reduction in attack rate vis-a-vis placebo.
Burt Adelman, M.D., Executive Vice President of Research and Development and Chief Medical Officer at Dyax, opined that receiving of Breakthrough Therapy designation is big achievement for DX-2930 development program. Adelman added that the firm is keen on taking complete advantage of opportunities that the treatment gives for maximizing possibility of fast path to approval.
A biopharmaceutical firm, Dyax, focuses on developing and commercialization of novel biotherapeutics for unmet medical needs.