New Anti-COVID-19 Medicines In India

Introduction

In light of the growing death toll and India battling against the second wave of COVID-19, the Govt. of India recently granted permission for emergency use of two anti-COVID 19 medicines, namely-,   2-DG by the Defence Research and Development Organisation (DRDO), in collaboration with Dr. Reddy’s Laboratories (DRL), Hyderabad, and Antibody Cocktail (Casirivimab and Imdevimab) by Roche India with Cipla Limited as a distribution partner.   2-deoxy-D-glucose, abbreviated to 2-DG, is an oral, therapeutic medicine and an antibody cocktail available in injectable form.  

2-DG is permitted by the Drugs Controller General of India(DCGI) for emergency use and as an adjunct remedy in moderate to severe COVID-19 patients. In contrast, the Central Drugs Standards Control Organisation (CDSCO) approved the antibody cocktail to treat confirmed cases of mild to moderate COVID-19 patients over 12 years of age at an increased risk of developing severe COVID-19 disease.

2DG as a Medicine

2DG is an oral medicine available on the doctor’s prescription only to hospitalized patients due to moderate to severe COVID-19. It is to be used as adjunct (add-on) therapy in addition to the current standard protocol.

The 2-DG comes in a sachet in the form of oral powder and can be consumed by dissolving in water. The dose and duration of this medicine will be determined by your treating doctor.

Origin of Anti-COVID Remedies

The 2-DG is an anti-COVID-19 medicine developed domestically. However, Roche will import the antibody cocktail, which will be made available in India with a contract with Cipla Ltd.

The 2-DG has been developed by the DRDO’s laboratory Institute of Nuclear Medicine and Allied Sciences, in alliance with Hyderabad-based pharma company Dr. Reddy’s Laboratories. It has gone through extensive clinical trials and was approved for emergency use following a green signal from the head of the apex body, the Drugs Controller General of India, on 1 May 2021.

Roche India has been given the Emergency Use Authorisation (EUA) for COVID-19 antibody-drug cocktails, Casirivimab and Imdevimab, to treat COVID-19 patients in India.

How Do Anti-COVID-19 Remedies Work?

The therapeutic anti-COVID-19 medicine 2-DG is a glucose analog or pseudo glucose. Any virus requires glucose for its growth and multiplication. It works by entering or accumulating into infected cells upon ingestion and preventing virus growth by blocking viral synthesis, multiplication, and energy production. Its accumulation, specifically in the virus-infected cells, makes its mechanism unique. This medicine is expected to save lives by its distinct action against coronavirus, which may also reduce the hospital stay of COVID-19 patients.  The Casirivimab–Imdevimab Antibody cocktail injection is a combination of two monoclonal antibodies. Monoclonal antibodies are laboratory-made proteins that mimic the action of immune cells and fight off pathogens such as viruses.  It works by blocking the attachment and entry of viruses into human cells and hence prevents the spread of infection

The antibody cocktail can be acquired by a doctor’s prescription only and should be administered in settings where healthcare providers have instant access to allergic reaction treatment, such as those used for anaphylactic shock.

The antibody cocktail jab effectively treats mild-to-moderate COVID-19 symptoms in children aged 12 years or older and weighing no less than 40 kg and adults. It especially treats those at high risk of getting a severe COVID-19 infection but may not need oxygen.

The cocktail drug can help high-risk patients before their condition worsens, reducing hospitalization risk and mortality rates by 70%. Further, it shortens the length of symptoms by about four days.

The intravenous (IV) administration takes about 20 to 30 minutes. Subcutaneously, four syringes of 2.5 ml (2 each of Casirivimab and Imdevimab) must be administered simultaneously at four different locations on the stomach or thigh.

Efficacy of Anti-COVID Remedies

The 2-DG drug trials carried out in over 110 patients in Phase- II and Phase-III clinical trials were conducted on 220 patients between December 2020 to March 2021 at 27 COVID hospitals in Delhi, Uttar Pradesh, West Bengal, Gujarat, Rajasthan, Maharashtra, Andhra Pradesh, Telangana, Karnataka, and Tamil Nadu.  

The cocktail trial conclusions are derived from Regeneron’s Phase 3 clinical trial, which is the foremost clinical trial to date that assessed COVID-19 treatment in patients who have COVID-19 but are not hospitalized. The trial included 4,567 patients who recently developed COVID-19 and were at high risk for a severe form of ailment. The 2,400-mg dose cut the hospitalization risk and death by 71%.

Conclusion

It is important to note that DRDO’s anti-COVID-19 medicine 2-DG  is an adjunct therapy and not a substitute for standard treatment. The drug pricing of 2-DG is yet to be determined based on its affordability, and the first 10,000 doses will be rolled out for public use this week. These doses have been recommended for use in moderate-to-severe COVID-19 cases only. 

The launching of this medicine amidst an ongoing battle between the country and the distressing second wave of the pandemic has been a sign of hope for many because it resolves the struggle for hospital-grade oxygen and hospital beds.

In this situation, 2-DG accelerates the recovery rate and decreases oxygen dependence, leaving the beds available for those patients who require critical care. We believe it is fair to put our faith in this medicine for all the right reasons mentioned above. Plus, it does not hurt that there will not be a needle involved in this procedure!

The medicine has been launched while the country battles the distressing second wave of the pandemic that has triggered a struggle for hospital-grade oxygen and hospital beds. In this situation, 2-DG accelerates the recovery rate and decreases oxygen dependence, leaving the beds available for those patients who require critical care. The antibody cocktail was administered to former US President Donald Trump after he was diagnosed with COVID-19.

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