Medical Dialogues
  • Dermatology
Login Register
This site is intended for healthcare professionals only
Login Register
  • MD Brand Connect
  • Vaccine Hub
  • MDTV
    • Breaking News
    • Medical News Today
    • Health News Today
    • Latest
    • Journal Club
    • Medico Legal Update
    • Latest Webinars
    • MD Shorts
    • Health Dialogues
  • Fact Check
  • Health Dialogues
Medical Dialogues
  • Medical News & Guidelines
      • Anesthesiology
      • Cardiology and CTVS
      • Critical Care
      • Dentistry
      • Dermatology
      • Diabetes and Endocrinology
      • ENT
      • Gastroenterology
      • Medicine
      • Nephrology
      • Neurology
      • Obstretics-Gynaecology
      • Oncology
      • Ophthalmology
      • Orthopaedics
      • Pediatrics-Neonatology
      • Psychiatry
      • Pulmonology
      • Radiology
      • Surgery
      • Urology
      • Laboratory Medicine
      • Diet
      • Nursing
      • Paramedical
      • Physiotherapy
  • Health news
      • Doctor News
      • Government Policies
      • Hospital & Diagnostics
      • International Health News
      • Medical Organization News
      • Medico Legal News
      • NBE News
      • NMC News
  • Fact Check
      • Bone Health Fact Check
      • Brain Health Fact Check
      • Cancer Related Fact Check
      • Child Care Fact Check
      • Dental and oral health fact check
      • Diabetes and metabolic health fact check
      • Diet and Nutrition Fact Check
      • Eye and ENT Care Fact Check
      • Fitness fact check
      • Gut health fact check
      • Heart health fact check
      • Kidney health fact check
      • Medical education fact check
      • Men's health fact check
      • Respiratory fact check
      • Skin and hair care fact check
      • Vaccine and Immunization fact check
      • Women's health fact check
  • AYUSH
    • Ayurveda
    • Homeopathy
    • Siddha
    • Unani
    • Yoga
  • State News
      • Andaman and Nicobar Islands
      • Andhra Pradesh
      • Arunachal Pradesh
      • Assam
      • Bihar
      • Chandigarh
      • Chattisgarh
      • Dadra and Nagar Haveli
      • Daman and Diu
      • Delhi
      • Goa
      • Gujarat
      • Haryana
      • Himachal Pradesh
      • Jammu & Kashmir
      • Jharkhand
      • Karnataka
      • Kerala
      • Ladakh
      • Lakshadweep
      • Madhya Pradesh
      • Maharashtra
      • Manipur
      • Meghalaya
      • Mizoram
      • Nagaland
      • Odisha
      • Puducherry
      • Punjab
      • Rajasthan
      • Sikkim
      • Tamil Nadu
      • Telangana
      • Tripura
      • Uttar Pradesh
      • Uttrakhand
      • West Bengal
  • Medical Education
      • Ayush Education News
      • Dentistry Education News
      • Medical Admission News
      • Medical Colleges News
      • Medical Courses News
      • Medical Universities News
      • Nursing education News
      • Paramedical Education News
      • Study Abroad
  • Industry
      • Health Investment News
      • Health Startup News
      • Medical Devices News
      • Pharma News
      • Pharmacy Education News
      • Industry Perspective
  • MDTV
      • Health Dialogues MDTV
      • Health News today MDTV
      • Latest Videos MDTV
      • Latest Webinars MDTV
      • MD shorts MDTV
      • Medical News Today MDTV
      • Medico Legal Update MDTV
      • Top Videos MDTV
      • Health Perspectives MDTV
      • Journal Club MDTV
      • Medical Dialogues Show
This site is intended for healthcare professionals only
LoginRegister
Medical Dialogues
LoginRegister
  • Home
  • Medical news & Guidelines
    • Anesthesiology
    • Cardiology and CTVS
    • Critical Care
    • Dentistry
    • Dermatology
    • Diabetes and Endocrinology
    • ENT
    • Gastroenterology
    • Medicine
    • Nephrology
    • Neurology
    • Obstretics-Gynaecology
    • Oncology
    • Ophthalmology
    • Orthopaedics
    • Pediatrics-Neonatology
    • Psychiatry
    • Pulmonology
    • Radiology
    • Surgery
    • Urology
    • Laboratory Medicine
    • Diet
    • Nursing
    • Paramedical
    • Physiotherapy
  • Health news
    • Doctor News
    • Government Policies
    • Hospital & Diagnostics
    • International Health News
    • Medical Organization News
    • Medico Legal News
    • NBE News
    • NMC News
  • Fact Check
    • Bone Health Fact Check
    • Brain Health Fact Check
    • Cancer Related Fact Check
    • Child Care Fact Check
    • Dental and oral health fact check
    • Diabetes and metabolic health fact check
    • Diet and Nutrition Fact Check
    • Eye and ENT Care Fact Check
    • Fitness fact check
    • Gut health fact check
    • Heart health fact check
    • Kidney health fact check
    • Medical education fact check
    • Men's health fact check
    • Respiratory fact check
    • Skin and hair care fact check
    • Vaccine and Immunization fact check
    • Women's health fact check
  • AYUSH
    • Ayurveda
      • Ayurveda Giuidelines
      • Ayurveda News
    • Homeopathy
      • Homeopathy Guidelines
      • Homeopathy News
    • Siddha
      • Siddha Guidelines
      • Siddha News
    • Unani
      • Unani Guidelines
      • Unani News
    • Yoga
      • Yoga Guidelines
      • Yoga News
  • State News
    • Andaman and Nicobar Islands
    • Andhra Pradesh
    • Arunachal Pradesh
    • Assam
    • Bihar
    • Chandigarh
    • Chattisgarh
    • Dadra and Nagar Haveli
    • Daman and Diu
    • Delhi
    • Goa
    • Gujarat
    • Haryana
    • Himachal Pradesh
    • Jammu & Kashmir
    • Jharkhand
    • Karnataka
    • Kerala
    • Ladakh
    • Lakshadweep
    • Madhya Pradesh
    • Maharashtra
    • Manipur
    • Meghalaya
    • Mizoram
    • Nagaland
    • Odisha
    • Puducherry
    • Punjab
    • Rajasthan
    • Sikkim
    • Tamil Nadu
    • Telangana
    • Tripura
    • Uttar Pradesh
    • Uttrakhand
    • West Bengal
  • Medical Education
    • Ayush Education News
    • Dentistry Education News
    • Medical Admission News
    • Medical Colleges News
    • Medical Courses News
    • Medical Universities News
    • Nursing education News
    • Paramedical Education News
    • Study Abroad
  • Industry
    • Health Investment News
    • Health Startup News
    • Medical Devices News
    • Pharma News
      • CDSCO (Central Drugs Standard Control Organisation) News
    • Pharmacy Education News
    • Industry Perspective
  • Home
  • News
  • Industry
  • Pharma News
  • Roche antibody...

Roche antibody cocktail for post-exposure prophylaxis of Covid-19 for adults gets CDSCO panel okay

Medical Dialogues TeamWritten by Medical Dialogues Team Published On 2021-09-21T17:05:59+05:30  |  Updated On 21 Sept 2021 5:05 PM IST
Roche antibody cocktail for post-exposure prophylaxis of Covid-19 for adults gets CDSCO panel okay
  • facebook
  • twitter
  • linkedin
  • whatsapp
  • Telegram
  • Email

New Delhi: With the aim of reducing the spread of the Covid-19 epidemic, the Subject Expert Committee (SEC), functional under the Central Drug Standard Organization (CDSCO), has recently approved pharma major Roche Products (India) Pvt Ltd's investigational antibody cocktail casirivimab and imdevimab for use in post-exposure prophylaxis of COVID-19 for adults ≥ 18 years of age.

However, in the case of children, the Subject Expert Committee (SEC) has requested the drug firm to submit safety data from the Post Marketing Surveillance (PMS) study in India in children for the use of the drug cocktail casirivimab and imdevimab in COVID-19 post-exposure prophylaxis.

This recommendation came in response to the proposal presented by drug-maker Roche Products (India) Pvt Ltd for approval of an additional indication for use of the antibody cocktail (Casirivimab and Imdevimab) in post-exposure prophylaxis of COVID-19 based on clinical data generated overseas.

Casirivimab is a monoclonal antibody combined with Imdevimab in Regeneron's antibody cocktail known as REGN-COV2 for the treatment of COVID-19.This drug is a combination of antibodies derived from humanised VelocImmune mice in addition to blood samples from patients who have recovered from COVID-19. These antibodies have been formulated to bind to multiple locations on the SARS-COV-2 spike protein, preventing viral escape.

Casirivimab and Imdevimab are monoclonal antibodies that are specifically directed against the spike protein of SARS-CoV-2, designed to block the virus' attachment and entry into human cells.

Earlier, the Medical Dialogues Team had reported that drug firm Roche India had received Emergency Use Authorisation (EUA) from the Central Drugs Standards Control Organisation (CDSCO) for Roche's investigational antibody cocktail used in the treatment of COVID-19."

Also Read: Roche India gets CDSCO nod to COVID antibody cocktail of Casirivimab, Imdevimab

The approval of the antibody cocktail of Casirivimab and Imdevimab in India was based on the data filed with the EUA in the US, and the scientific opinion of the Committee for Medicinal Products for Human Use (CHMP) in the European Union.

It was also reported that the first batch of the Antibody Cocktail (Casirivimab and Imdevimab) was launched in the Indian market a few months ago, in a strategic partnership between Roche India and Cipla Limited. Further, it was said that Cipla will distribute the product across the country and the drug will be available through leading hospitals and COVID treatment centers.

Now in continuation, at a recent SEC committee meeting, the SEC committee thoroughly examined the proposal presented by Roche Products (India) Pvt Ltd for approval of an additional indication for use of the drug in post-exposure prophylaxis of COVID-19 based on clinical data generated overseas.

The committee noted that the additional indication is approved in the US, UK, and France.

After detailed deliberation, the committee concluded,

"The committee recommended grant of additional indication for post-exposure prophylaxis inline with US-FDA for adults ≥ 18 years of age. Further, the committee recommended that the firm should submit the safety data from the PMS study in India in children for consideration of the extension of indication to children."
Also Read: First: Roche- CIPLA Antibody Cocktail of Casirivimab and Imdevimab for mild to moderate COVID-19 now available in India
roche indiacasirivimabimdevimabpost exposure prophylaxiscdscosec committeecovid19rocheusfda
Medical Dialogues Team
Medical Dialogues Team
    Show Full Article
    Next Story

    Editorial

    Real-World Case study: Darbepoetin Alfa for Chemotherapy-Induced Anemia in Metastatic Breast Cancer - Dr Aditya Murali

    Real-World Case study: Darbepoetin Alfa for Chemotherapy-Induced Anemia in Metastatic Breast Cancer...

    Aspirin in Primary Prevention- When to Consider?

    Aspirin in Primary Prevention- When to Consider?

    Featured image representing medico legal

    What's the Role of Expert Opinion in Medical Negligence?

    7- Point Discharge Protocol for AECOPD: Time to Inculcate in Practice

    7- Point Discharge Protocol for AECOPD: Time to Inculcate in Practice

    Aspirin Use in Women Aged 40-50 with Diabetes and Hypertension: Identifying the Ideal Candidates

    Aspirin Use in Women Aged 40-50 with Diabetes and Hypertension: Identifying the Ideal Candidates

    View All

    Journal Club Today

    High Blood Pressure in Children Tied to Mothers Pregnancy Health: NIH Study Finds

    High Blood Pressure in Children Tied to Mother's Pregnancy Health: NIH Study Finds

    View All

    Health News Today

    Health Bulletin 10/ May/ 2025

    Health Bulletin 10/ May/ 2025

    View All
    © 2022 All Rights Reserved.
    Powered By: Hocalwire
    X
    We use cookies for analytics, advertising and to improve our site. You agree to our use of cookies by continuing to use our site. To know more, see our Cookie Policy and Cookie Settings.Ok