Drug firm Wockhardt today said a product from its new drug discovery programme, which aims to treat pneumonia, has received QIDP status from the US health regulator.
Qualified Infectious Disease Product (QIDP) status is given by the US Food and Drug Administration (USFDA) to drugs, identified by CDC (Centre of Disease Control, US) that act against pathogens, which have high degree of unmet need in their treatment.
QIDP status provides fast-track clinical development and review of the drug application by FDA for approval and a five year extension of market exclusivity post product approval in the US.
Wockhardt Chairman Habil Khorakiwala said: "We are pleased that WCK 4873 has received the QIDP status, third for the company. WCK 4873 is a new class of antibiotic drug, which will be used for treatment of community acquired bacterial pneumonia (CAPB)...."
There is a global crisis of availability of antibiotics to fight the resistant bacteria, he added.
WCK 4873 will be entering phase II global clinical trials this year.
Emphasising that India should also follow the USFDA steps, Khorakiwala said: "Indian regulator also needs to recognise this crisis and evolve new regulatory pathway for faster clinical trials and approvals on line with USFDA."
The company has already received QIDP status for WCK 771 and WCK 2349, which are effective in hospital acquired bacterial pneumonia and skin structural infections (SSSI) caused by a class of pathogens.
Wockhardt shares today closed at Rs 1,407.15 apiece on the BSE, up 0.78 per cent.
