Wockhardt gets special status in US for antibiotics

Drug-maker Wockhardt Ltd has received the special QIDP status from the US Food and Drug Administration on an antibiotic product being developed by the company.

The Qualified Infectious Disease Product (QIDP) designation was created by the US regulatory system to facilitate the development of new antibiotics. It was constituted under Generating Antibiotic Incentives Now (GAIN) Act in 2012 as part of the FDA Safety and Innovation Act. And under this special status, drugs are given fast track approvals and an extended five-year market exclusivity.

In its latest announcement, Wockhardt said WCK 4873, a product from its New Drug Discovery programme, was granted the QIDP status, making it the third from the company. The other two products included WCK 771 and WCK 2349 that received this status last year.

Habil Khorakiwala, Wockhardt’s Chairman, said WCK 4873 was a new class of antibiotic drug that targeted 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,” he added.

In the US and Europe, more than 50000 deaths are reported every year because of resistant pathogens. Business Line