Assam Scientist-Developed Antibiotic Gets US FDA Approval

GUWAHATI: A molecule, Enmetazobactam, for which a team of scientists, including Assam’s Dr. Mukut Gohain, received a US patent as one of the inventors in 2008, has now received the green light to hit the market after a long 16 years following approval from the US Food and Drug Administration last week.

The US agency has approved it as an antibiotic to treat critical urinary tract infections (UTIs). Enmetazobactam is the first antibiotic invented by Indian scientists to receive approval from the US FDA.

According to the US Food and Drug Administration, the antibiotic will be available under the name ‘Exblifep,’ with Enmetazobactam as one of the active ingredients, and has been approved to treat complicated urinary tract infections.

Simultaneously, the European Medicines Agency (EMA) has also recognized this antibiotic for the treatment of UTIs and pneumonia.

After the invention of the molecule and obtaining the patent, with high hopes, pre-clinical trials and experiments started simultaneously. In collaboration with Allecra Therapeutics, Germany, three-phase clinical trials were conducted in the last 16 years, and finally, approvals from the US FDA and EMA, the two government regulators in the US and Europe, have been obtained.

“Enmetazobactam is the first antibiotic invented by Indian scientists from Orchid Pharma, Chennai, to receive US FDA approval. The US FDA approval is a significant milestone for our team because Enmetazobactam is now allowed to be marketed. No antibiotic invented by Indian scientists had received US FDA approval before this,” Gohain, principal investigator and head of the Research and Development Department at Chemical Process Technologies based in Pretoria, South Africa, and co-inventor of Enmetazobactam, told TOI.

He mentioned that an Indian pharmaceutical company has initiated the process to make this antibiotic available in India, while in the US, another company has taken the lead to make it available in the market in the days to come.

“The success rate of Enmetazobactam is 79.1 percent. Being a new antibiotic, it has higher efficacy because already available antibiotics may not be as effective as they were initially,” Gohain said.

Starting from his school education in the government-run Barchapari Primary School to attaining a PhD from NEIST, Jorhat, Gohain spent valuable years of his life in Assam until he shifted his workplace to Chennai, Spain, and finally South Africa. The renowned scientist, who hails from Gondhia Gaon village, Panitola, in upper Assam’s Tinsukia district, is a leading figure of the nine-member team of scientists and microbiologists.

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