Wockhardt's WCK 4873, a product from their new drug discovery programme, has received Qualified Infectious Disease Product (QIDP) status from US Food and Drug Administration (US FDA). This is the third product Wockhardt getting this coveted status after WCK 771 and WCK 2349 last year, and provides a strong boost to its drug development programme.
Dr. Habil Khorakiwala, Wockhardt’s chairman says, “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 the treatment of Community Acquired Bacterial Pneumonia (CABP) which has risen by alarming proportions globally”
Dr Khorakiwala further adds, “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 50,000 deaths every year because of these resistant pathogens. Early identification of antibiotic crisis by Wockhardt has resulted in this unique achievement”.
QIDP status for WCK 4873 is significant achievement in line with same received earlier for WCK 771 and WCK 2349 which are effective in treatment of Hospital Acquired Bacterial Pneumonia (HABP) and Skin & Skin Structure Infections (SSSI) caused by a class of pathogens called MRSA (Methicillin-resistant Staphylococcus Aureus). WCK 4873 will be entering its Phase 2 global clinical trials later this year.
QIDP status is granted to drugs, identified by Centre for Disease Control (CDC), 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 US FDA Safety and Innovation Act to underline the urgency in new antibiotics development.