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news.Indian drug-maker Wockhardt has received Qualified Infectious Disease Product (QIDP) designation from the US Food and Drug Administration (FDA) for one of its product, WCK 4873, for the treatment of pneumonia.
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This is the company’s third product to receive this QIDP status after WCK 771 and WCK 2349 last year further strengthening its new drug discovery program.
QIDP status is given by the US health regulator to drugs, identified by the Centre of Disease Control (CDC) to act against pathogens, which have a high degree of unmet need in their treatment.
Wockhardt chairman Dr Habil Khorakiwala said: "WCK 4873 is a new class of antibiotic drug which will be used for the treatment of Community Acquired Bacterial Pneumonia (CABP) which has risen by alarming proportions globally.
"There is a global crisis of availability of antibiotics to fight resistant bacteria. Indian regulator also needs to recognise this crisis and evolve new regulatory pathway for faster clinical trials and approval on the lines of the US FDA.
"In fact, crisis in India for bacterial drug resistant is significantly high and we are losing lives every day.
"In US and Europe there are more than 50000 deaths every year because of these resistant pathogens. Early identification of antibiotic crisis by Wockhardt has resulted in this unique achievement."
The company has already secured QIDP status for WCK 771 and WCK 2349, which are effective in hospital acquired bacterial pneumonia (HABP) and skin structural infections (SSSI) caused by a class of pathogens called Methicillin-resistant Staphylococcus Aureus (MRSA).