Wockhardt receives US FDA's drug discovery status for new antibiotic

The US Food and Drug Administration (FDA) has granted Wockhardt’s WCK 5222, a product from its breakthrough new drug discovery program in anti-infectives, Qualified Infectious Disease Product (QIDP) status. This is the fourth product from Wockhardt to receive this coveted status. During last year, Wockhardt received approval for WCK 771 & WCK 2349 and in early this year approval was received for WCK 4873. The only company globally to receive QIDP status for four drugs from US FDA.
 
QIDP status is granted to drugs, identified by CDC (Centre for Disease Control, USA), that act against pathogens which have a high degree of unmet need in their treatment. QIDP status provides fast track clinical development and review of the drug application by US FDA for drug approval and a five-year extension of market exclusivity post product approval in the USA. QIDP was constituted under Generating Antibiotic Incentives Now (GAIN) Act in 2012 as part of the FDA Safety and Innovation Act to underline the urgency in new antibiotics development.
   
Dr Habil Khorakiwala, chairman, Wockhardt, said, “WCK 5222 is a new class of antibiotic for gram negative terrain for complicated urinary tract infections and hospital acquired bacterial pneumonia (HABP)/VABP. We believe that when WCK 5222 is approved will save many lives worldwide.”
 
Dr Khorakiwala further added that there is a global crisis of availability of antibiotics to fight resistant bacteria and there has been a big void in anti-infective as relatively very few drugs have been discovered in the last decade.
 
With the rise in number of new organisms and new strains of old organisms with significant resistance for existing medicines, Wockhardt with its array of under development drugs in this space aims to counter these unmet needs in both gram positive and gram negative bacterial infections in both regulated and unregulated markets.