Assam Scientist-Developed Antibiotic Gets US FDA Approval
GUWAHATI: In a landmark move, Enmetazobactam, a molecule for which a team of scientists, including Assam’s Dr. Mukut Gohain, was granted a US patent as one of its inceptors back in 2008, has now received the go ahead to enter the market after a long wait of 16 years after it was approved by the US Food and Drug Administration last week.
It was approved as an antibiotic by the US agency to treat critical urinary tract infections (UTIs).
It is to be noted that Enmetazobactam happens to be the first antibiotic invented by Indian scientists to be approved by the US FDA.
As per the US Food and Drug Administration, the antibiotic will be available under the name ‘Exblifep,’ with Enmetazobactam as one of its active ingredients, and has been green-lighted to cure complex urinary tract infections.
At the same time, this antibiotic has also been recognized by the European Medicines Agency (EMA) for the treatment of UTIs and pneumonia.
With a quest for a desirable outcome, pre-clinical trials and experiments started simultaneously after the molecule was invented and the patent was obtained.
Three-phase clinical trials were carried out in the last 16 years in collaboration with Allecra Therapeutics, Germany.
Finally, the US FDA and EMA, the two government regulators in the US and Europe, have approved this crucial antibiotic.
“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.
The Assamese scientist revealed that an Indian Pharmaceutical company has taken the initiative of launching this antibiotic in India, while in the US, another company has taken the lead to make it available in the market in the near future.
“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.
