Wockhardt drug discovery gets fast track approval from USFDA
Sep 01 2014 , Mumbai
This is the first instance of an Indian pharmaceutical company receiving a QIDP status, Wockhardt said in a release issued here.
"This is indeed a proud moment for us. Not only does the status allow for fast track review of our drug application, it also grants a five year extension to the drug patents in USA, which is a major support for the commercial aspect of the drug. These drugs will be entering in their global Phase-3 clinical trials early next year," Wockhardt Founder Chairman and Group CEO Habil Khorakiwala said.
A QIDP status is granted to drugs, which act against pathogens that have a high degree of unmet need in their treatment and are identified by the Centre for Disease Control, USA - a top US government health and safety body.
QIDP status allows for fast track review of the drug application by US FDA paving way for an early launch.
Globally, there is a significant antibiotic vacuum due to dual impact of rise in new resistant pathogens and declining research in this area, the statement said.
Over the years, Wockhardt has developed a strong anti-infective program which focuses on development of drugs which target this antibiotic gap.
Both WCK 771 and WCK 2349 act against one of the globally rising class of pathogens, MRSA (Methicillin-resistant Staphylococcus Aureus) which causes a range of diseases from the skin infection to severe respiratory infections.
In case of severe infections like Hospital Acquired Pneumonia (HAP), current medical cure has a very limited reach causing a high unmet need and mortality.