Wockhardt receives DCGI approval for two new antibiotics

Indian drug regulator, DCGI has approved Wockhardt's 2 new antibiotics, EMROK (IV) and EMROK O (Oral), for acute bacterial skin and skin structure Infections including diabetic foot infections and concurrent bacteraemia based on the Phase 3 study involving 500 patients in 40 centres across India. The new drug will target superbug like Methicillin resistant Staphylococcus aureus (MRSA), which is a leading cause of rising antimicrobial resistance (AMR).

EMROK and EMROK-O are the first novel chemical entity antibiotics researched and developed in India with various international collaborations across globe. While the non-clinical and Phase 1 studies have been undertaken in U.S. Europe and India, the Phase 2 and Phase 3 clinical studies have been successfully completed in India.

 

Clinical and non-clinical studies have established advantageous safety features of EMROK/EMROK-O compared to older MRSA drugs vancomycin, teicoplanin, daptomycin and linezolid which are beset with unfavourable features of nephrotoxicity, bone-marrow toxicity and muscle toxicity therefore cannot be given in patients with impaired kidney/liver function and seriously ill patients requiring for longer duration therapy.

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