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Promising antibiotics — a lifeline India is waiting

The fight against drug-resistant illnesses has reached a tipping point, and the necessity for effective antibiotics cannot be stressed. In a recent occurrence, a team of doctors confronted a difficult situation that demonstrated the crucial need of acting quickly.

Extensively Drug-Resistant Pseudomonas aeruginosa

  • A brave 18-year-old patient fought not just T-cell leukaemia but also an aggressive and resistant strain of Pseudomonas aeruginosa in an intensive care unit.
  • With little treatment options available due to the bacterium’s great resistance to antibiotics, the patient’s condition rapidly deteriorated.
  • The illness attacked his lungs, causing persistent fever spikes and significant facial damage. Time was ticking away, and his life was on the line.
  • Indian Antibiotic Development Innovation
  • Combination that works: Cefepime/zidebactam is a novel antibiotic developed by Indian scientists. It combines two active ingredients to attack drug-resistant gram-negative bacteria like Pseudomonas aeruginosa.

Promising Results

  • This Indian discovery has demonstrated exceptional potential in fighting drug-resistant diseases. It has undergone phase 3 trials on a global scale, demonstrating its efficacy and safety profile.
  • Compassionate Use: In a compelling instance, an 18-year-old patient with T-cell leukaemia and an extensively drug-resistant strain of Pseudomonas aeruginosa recovered miraculously after taking cefepime/zidebactam under a compassionate use regimen. This demonstrates the antibiotic’s life-saving potential.
  • The remarkable case of the patient’s recovery highlights the critical need for Emergency Use Authorization (EUA) for antibiotics such as cefepime/zidebactam that have demonstrated promising benefits in phase 3 trials or have been licenced in other countries. The provision of EUA would allow for prompt access to this excellent therapeutic option.
  • India can enhance its armoury against drug-resistant diseases by recognising the value of cefepime/zidebactam and expediting its EUA. This Indian breakthrough has the potential to make a big contribution to resolving the global problem of drug resistance.
  • Potential Global Impact: Granting EUA for cefepime/zidebactam not only saves lives in India, but also helps countless people throughout the world who are in critical need of viable treatment alternatives. India’s scientific breakthroughs have the potential to have a significant impact on the global scene.
  • Cefepime/zidebactam is a remarkable example of India’s scientific excellence in the realm of antibiotic discovery. It demonstrates the country’s ability to develop and give solutions to drug-resistant illnesses.

The Dreadful Situation and the Disturbing Reality

  • Potent Antibiotics are in short supply: The severe scenario stems from a lack of effective medications to tackle drug-resistant diseases. Antibiotics that are now accessible have lost their potency due to developing resistance, leaving healthcare providers with little therapeutic alternatives.
  • Countless lives are at risk due to insufficient antibiotics, which is a heartbreaking truth. Patients, particularly the critically ill and immunocompromised, are succumbing to infections that were previously manageable. This has a considerable impact on morbidity and death rates.
  • Current Antibiotics’ Ineffectiveness: Antibiotics that were once successful against strong diseases have become useless due to rising drug resistance. Doctors face a tremendous hurdle in providing effective treatment due to bacteria’s continual development and mutation.
  • Doctors encounter a variety of obstacles when dealing with drug-resistant illnesses. They must negotiate a dwindling arsenal of effective antibiotics, resulting in fewer options and the usage of suboptimal treatments. This condition adds enormous strain and powerlessness to front-line doctors.
  • High mortality Toll: The dreadful situation and devastation lead to a high mortality toll from drug-resistant diseases. Millions of lives are wasted each year as a result of antibiotics’ inability to properly treat these powerful diseases.
  • Healthcare personnel are continuously racing against the clock, striving to keep one step ahead of evolving microorganisms. Doctors are stressed by the need to develop effective answers as well as the aggravation of not having access to life-saving antibiotics in crucial cases.
  • The dreadful condition and devastating reality of drug-resistant diseases is a worldwide concern. To address the problem and develop successful remedies, healthcare officials, lawmakers, researchers, and pharmaceutical corporations must work together.

What exactly is an Emergency Use Authorization (EUA)?

  • During public health emergencies, EUA is a regulatory procedure that provides for the rapid authorisation and use of medical items.
  • Medical items, such as vaccinations, treatments, and diagnostics, can be made available for use in emergency situations under EUA before they get full approval or licensure. This enables a faster response to public health disasters like epidemics or pandemics by enabling access to potentially life-saving interventions.
  • EUA entails a thorough examination procedure by regulatory authorities, who consider existing scientific information, safety data, and the possible advantages and dangers of the medical product.

The Importance of EUA

  • Treatment Options Are Limited: When faced with extremely drug-resistant illnesses, treatment choices become restricted and frequently futile. Conventional antibiotics may be ineffective against these diseases, resulting in longer sickness and higher mortality rates.
  • Infections that can kill you: Drug-resistant illnesses can endanger patients’ lives, particularly those who are immunocompromised or seriously ill. To battle these infections and improve patient outcomes, immediate access to appropriate medicines is critical.
  • Time is of the importance in some circumstances, and delays in receiving appropriate therapies can have serious implications. In an emergency, EUA allows for faster permission and access to potentially life-saving measures.
  • Addressing Public Health Emergencies: The EUA plays a critical role in responding to public health emergencies such as outbreaks or pandemics, where quick action is required to deploy interventions that can save lives and reduce infection spread.
  • Balancing While EUA facilitates access to therapies, safety and efficacy remain key issues. To guarantee that authorised treatments satisfy the requisite requirements for patient safety and effectiveness, rigorous review and monitoring are required.
  • Supporting Research and Development: EUA can help make vital medications that are still in clinical trials available to patients who have no other viable options. This enables the collection of real-world data and insights that may be used to influence future R&D initiatives.
  • Global Collaboration: EUA for important treatments can also facilitate global collaboration and exchange of information and resources. It enables countries to collaborate on public health issues and ensures fair access to life-saving therapies.

@the end

The 18-year-old patient’s recovery highlights the need for Emergency Use Authorization (EUA) for essential antibiotics like cefepime/zidebactam and cefiderocol to combat drug-resistant infections and save lives globally.

Source: https://www.thehindu.com/opinion/op-ed/antibiotics-with-promise-a-lifeline-india-awaits/article67042343.ece
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