Wockhardt Granted Indian Regulatory Approval on new Antibiotics


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▴ Wockhardt
Wockhardt: 1st Indian Company to Achieve Approval for New Discovered 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).


The size of Indian Antibiotic market is approx. 16,000 Crore, growing at 7% and is one of the largest
therapeutic segment, with a 12% market share of the Indian Pharmaceutical Market1.
“By virtue of its broad spectrum activity against widely prevalent pathogens including MRSA, superior safety
over the currently available anti-MRSA agents and its unique properties, I believe EMROK/EMROK-O has a
strong potential to effectively address the unmet medical need of the clinicians in the country thereby helping
to reduce the morbidity and mortality”- said Dr. Habil Khorakiwala, Founder Chairman, Wockhardt Group.
Antimicrobial Resistance: A Medical Challenge (38% Resistance in India)
AMR is a major public health problem globally. India carries one of the largest burdens of drug‑ resistant
pathogens worldwide. Infections caused by drug-resistant organisms could lead to increased mortality and
prolonged duration of hospitalization, causing a huge financial burden to the affected persons, health-care
systems, and hinder the goals of sustainable development. Two million deaths are projected to occur in India
due to AMR by the year 2050.


World Health Organisation (WHO) in 2017 has listed Methicillin resistant S. aureus (MRSA) as a ‘high’ priority
pathogen due to high prevalence of resistance, mortality rate, burden on community and health care settings3.
In 2018, a national study conducted by the Indian council of Medical research (ICMR) and Anti-microbial
resistant surveillance network (AMRSN) group highlighted the high prevalence of 38.6% of MRSA in India4. A
recent Indian study reports that 1 in 6 patients infected with multidrug resistant Gram positive infections die
in intensive care units5.


Limitations of Current Treatments :


Currently available anti-MRSA agents have multiple side effects such as kidney damage, decrease in platelet
cell counts, muscle pain, to name a few6; which limits their use for a longer period and compromise the safety
of critically ill patients in the ICU. The patient management is further complicated due to increasing resistance
to these agents and drying antimicrobial pipeline.

Tags : #wockhardt #discoverednewantibiotics #approvedbydcgi #medicircle

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