Jubilant Life Sciences launches Remdesivir injection in India for Rs. 4,700 per vial, the only antiviral drug approved by the USFDA

Remdesivir
Remdesivir

On Monday, Jubilant Life Sciences announced that Jubilant Generics launched Remdesivir for injection. It was launched under the brand name Jubi-R with a price tag of Rs. 4,700 per vial of 100 mg.

The company will distribute the injection in over 1000 hospitals across India to provide COVID19 treatment in India.

Gilead Sciences, Inc. and Jubilant went into an agreement in May 2020. This deal provided Jubilant with a non-exclusive license to manufacture and sell the remdesivir drug in 127 countries including India.

Gilead’s investigational drug remdesivir is the only antiviral drug that has been granted Emergency Use Authorization (EUA) by the USFDA for treatment against COVID-19 for both children and adults. Drug Controller General of India (DCGI) permitted Jubilant to manufacture and market the drug in July 2020. This drug is to be marketed in 100 mg per vial lyophilized injection and used only in an emergency in COVID-19 treatment.

In a regulatory filing, the company informed that the drug, remdesivir, will need intravenous administration in a hospital, under the supervision of a medical practitioner.

Comments from the company’s Chairman:

Shyam S. Bhartia, Chairman & Managing Director and Hari S. Bhartia, Co-Chairman, Jubilant Pharma Limited commented, “It gives us immense satisfaction to launch ‘JUBI-R’ as this drug has a potential to save precious lives across the globe. We have launched the product at affordable prices and strive to make it available in sufficient quantities to meet the high demand for the drug in the Indian market and other countries”.

He also praised the company’s ability to launch the product in a short time and added that this development highlights its R&D development capabilities and its commitment to provide leading healthcare solutions. He also added that the Jubilant Bhartia Foundation will distribute the drug on a compassionate basis to save people’s lives by unique programs.

 

What is remdesivir?

An antiviral drug that is prepared to tackle against the coronavirus (COVID-19) disease is caused by the SARS-CoV-2 virus. Some people who are admitted to hospitals might benefit from the drug which generally focuses on shortening the recovery time.

Though there is no-FDA approved vaccine against the COVID-19 disease, FDA has provided remdesivir Emergency Use Authorization (EUA) which will allow children and adults who are hospitalized due to severe cases of Covid-19 use the injection.

Why is remdesivir prescribed?

The injection works as an antiviral which stops spreading the virus. It is only prescribed for certain hospitalized adults and children.

Any special precautions to follow for use of the drug?

 

  1. Inform your doctor if you are allergic to remdesivir or any other medicines or any of the ingredients of the remdesivir injection. You can know about the ingredients of your pharmacist.
  2. Inform your doctor of the other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products that you consume or might consume. If you were previously or at that time provided with chloroquine or hydroxychloroquine (Plaquenil) don’t forget to tell your doctor. Depending on this the pharmacist might alter the dose and also might need to supervise your side effects.
  3. Also, inform your doctor of liver and kidney disease.
  4. Inform your doctor if you are pregnant or if you are currently breastfeeding.

Some effects to look out for:

Mild:

pain, bleeding, bruising of the skin, soreness, or swelling near the place where the medication was injected

Serious:

Also if you experience yellow eyes or skin; dark urine; or pain or discomfort in the right upper stomach area inform your doctor instantly.

(Also inform your doctor if you come across any other unusual effect)

Other research information:

Gilead Sciences, in 2009, developed the drug remdesivir as the company’s R&D program against Hepatitis C. Though the drug was not effective as such against Hepatitis C, later it was found to be useful for the treatment of Ebola virus and Marburg virus. A collaborated research of CDC and Gilead sciences found the drug to be useful against multiple filoviruses, pneumoviruses, paramyxoviruses, and coronaviruses.

United States Army Medical Research Institute of Infectious Diseases (USAMRIID) in 2015 reported that the drug had blocked the Ebola virus in Rhesus monkeys in a preclinical result. During the West African Ebola virus pandemic, the drug was pushed through different trials and was then used in people with the disease. During the Kivu Ebola emergency, the drug was used. In August 2019, Congolese health officials announced that the drug though being safe and somewhat effective was less effective than monoclonal antibody treatments such as mAb114 and REGN-EB3.

Being reported as active against severe acute respiratory syndrome (SARS) and the Middle East respiratory syndrome (MERS) in animal models, the drug began development by Gilead Sciences in January 2020. In a trial in China from February to March 2020, the drug failed to reduce the time for improvement and showed adverse effects. In April 2020, with more research and trials the drug got labeled as the most promising treatment for COVID-19.

On 1st May the FDA said that the potential benefits of the drug outweighed the risks for patients with severe coronavirus.

Experts from the British Medical Journal said, “the drug probably has no important effect on the need for mechanical ventilation and may have little or no effect on the length of hospital stay”. Though due to the high price of the drug, it might divert funds from potential research and development of other Covid-19 treatments.

DCGI has approved the Serum Institute of India to conduct Phase 2 & 3 human trials of the COVID vaccine.

 

 

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