FDA gives Fast Track Designation for MediciNova, Inc. (NASDAQ:MNOV)’s MN-001, Shares Up 45% Print
By Josh Gee   
Thursday, 16 April 2015 15:15

Shares of MediciNova, Inc.(NASDAQ:MNOV) skyrocketed 45% to $5.08 as the company has confirmed receiving Fast Track designation from U.S. Food and Drug Administration for MN-001 that treats patients with nonalcoholic steatohepatitis (NASH) with fibrosis.

 

Fast Track is a method made for making it easy and speeding up the review of drugs which are aimed at treating serious or life-threatening diseases along with showing potential of addressing unmet medical needs for those kinds of diseases.

A vital feature of the Fast Track program is that it lays stress on constant communication between the sponsor and FDA throughout the drug development along with reviewing process for improving efficiency of product development.

This can ensure a less timeline for the final part of the drug approval.

In January 2015, MediciNova had confirmed starting an Investigational New Drug (IND) application for MN-001 in NASH. Due to safety information from prior clinical studies of MN-001, FDA has accepted MediciNova moving with a Phase 2 study along with first clinical study of MN-001 in NASH.

Yuichi Iwaki, MD, PhD, President and Chief Executive Officer of MediciNova, opined that the firm is glad that MN-001 has got the Fast Track designation and he stated that it is a proof of the potential in addressing unmet medical needs in life-threatening disease.

Iwaki hopes to provide more updates on the development progresses.

A fast track designation must be given if it is meant for treatment of life-threatening disease and if it demonstrates the potential of addressing unmet medical needs for the condition. Priority Review along with an FDA goal for finishing review in six months of submission as well as the facility of a sponsor submitting sections of the New Drug Application (NDA) for review by FDA are some of the other facilities that one gets. Nonalcoholic steatohepatitis (NASH) is a condition which witnesses fat in the liver along with inflammation.

 




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