Drug maker Wockhardt has received qualified disease product (QIDP) status from US health regulator for a new antibiotic.
The company has received the coveted status from the US Food and Drug Administration (USFDA) for ‘WCK 5222’, a product from its new drug discovery programme in anti-infectives, Wockhardt said in a filing to the BSE.
“We are pleased that WCK 5222 has received the QIDP status, fourth for the company in quick succession. WCK 5222 is a new class of antibiotic for gram negative terrain for complicated urinary tract infections and hospital acquired bacterial pneumonia,” Wockhardt Chairman Habil Khorakiwala said.
The company believes that when 5222 is approved, it will save many lives worldwide, he added.
“The company’s relentless focus for almost two decades in the anti infective space has started showing recognition with consecutive approvals for QIDP in quick succession,” Khorakiwala said.
He added that there is a global crisis of availability of antibiotics to fight resistant bacteria and there has been a big void in anti infectives as relatively very few drugs have been discovered in the last decade.
QIDP status is granted to drugs identified by Centre for Disease Control, US, that act against pathogens which have a high degree of unmet need in their treatment.
The status provides fast track clinical development and review of the drug application by the USFDA for drug approval and a five year extension of market exclusivity post product approval in the US.
Wockhardt stock closed the day at Rs 1,637.25, down 0.87 per cent, on the BSE.