The US FDA (Food and Drug administration) recently granted a Fast Track designation to MediciNova’s novel drug formulation MN-001 (tipelukast) aimed at treating patients with idiopathic pulmonary fibrosis (IPH). This announcement, which was made in a press release by MediciNova on September 10, 2015, comes nearly a year after the FDA granted an Orphan Drug Designation to tipelukast in October 2014.
MN-001 is an oral, small molecule formulation developed by MediciNova that has shown anti-fibrotic and anti-inflammatory activities in pre-clinical models via several mechanisms like inhibition of phosphodiesterases (PDE) (mainly 3 and 4), and inhibition of 5-lipoxygenase (5-LO) and leukotriene (LT) receptor antagonism, the latter two being novel anti-fibrotic mechanisms. Down-regulation of pro-fibrotic genes like LOXL2, Collagen Type 1 and TIMP-1, and pro-inflammatory genes like CCR2 and MCP-1 also contribute to the drug’s mechanism of action in IPF lungs.
The Fast track designation is granted to drugs in order to facilitate and speed-up the clinical development of new therapies, which eventually leads to a shortened timeline between the development process and eventual approval by the FDA. Drugs are typically fast-tracked by the FDA when they are indicated to treat diseases with serious unmet medical needs, as is the case with pulmonary fibrosis.
A Fast Track designation offers drug developers several key advantages, including more face-to-face meetings with FDA officials to discuss the drug’s development plans and a more hands-on approach by the FDA to pave the way for the drug’s eventual marketing and commercialization. Fast track designation also facilitates accelerated approvals based on clinically relevant endpoints, which may or may not be the actual primary or secondary endpoints but are clearly predictive of the clinical benefit of the drug, as well as priority review of all data and documents within six months of submissions and rolling reviews of every section of the New Drug Application (NDA) submitted by sponsors separately, rather than waiting for every section to be completed before submitting the application.
Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, Inc., commented, “We are very pleased that MN-001 has received Fast Track Designation for IPF and believe this validates its potential to address unmet medical needs in this life-threatening disease. We look forward to providing further updates as our development program progresses.”