• Email Us: [email protected]
  • Contact Us: +1 718 874 1545
  • Skip to main content
  • Skip to primary sidebar

Medical Market Report

  • Home
  • All Reports
  • About Us
  • Contact Us

Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19

October 8, 2021 by David Barret Leave a Comment

October 8, 2021

By Shivani Singh, Anuron Kumar Mitra and Neha Arora

BENGALURU (Reuters) -Two Indian drugmakers have requested permission to end late-stage trials of their generic versions of Merck & Co’s promising experimental oral antiviral drug molnupiravir to treat moderate COVID-19, a week after Merck said its own trial had succeeded for mild-to-moderate patients.

Merck earlier this year suspended its own development of molnupiravir https://ift.tt/3mvNjgG as a treatment for hospitalized COVID-19 patients since many of them have reached a phase of the disease that is too late for an antiviral drug to provide much help.

The Indian companies – Aurobindo Pharma Ltd and MSN Laboratories – did not exclude hospitalized patients in designing their moderate COVID-19 trials, according to study documents, although it was not known if the trials ultimately included people in the hospital.

Merck spokesperson Melissa Moody said Merck and the Indian companies had defined “moderate” disease differently.

Merck’s trials are based on U.S. Food and Drug Administration definitions, which for moderate COVID-19 describe blood oxygen levels as no lower than 93%. It defines blood oxygen levels for severe COVID-19 as 93% or lower.

The trials in India define moderate COVID-19 blood oxygen levels as 90% to 93%, according to the trial documents for the two companies.

Aurobindo and MSN are continuing to conduct studies of molnupiravir in patients with mild COVID-19 who have not been hospitalized, according to trial documents and the website of the Indian drug regulator’s internal expert committee.

Merck and partner Ridgeback Biotherapeutics last week said molnupiravir had nearly halved the risk of hospitalization https://ift.tt/3mlaGtl or death in at-risk non-hospitalized patients with mild-to-moderate COVID-19, results hailed by experts as potentially a major advance in fight against the illness.

The Indian drug regulator’s committee also disclosed on its website that Aurobindo and MSN had presented interim clinical trial data for moderate COVID-19 patients and asked to end the trials.

A source with the Drug Controller General of India said the pill has not shown “significant efficacy” https://ift.tt/3FqJHFo against moderate COVID-19, though it was having success against mild cases.

An Aurobindo spokesperson did not comment on the effectiveness of the drug in its trial. The spokesperson said the company had “faced challenges in patient recruitment at this juncture” for its trial in moderate COVID-19 patients, adding “we are evaluating the further course of action.”

Aurobindo started the planned 100-patient trial of its generic version of the Merck pill against moderate COVID-19 in August, and is also running a trial that hopes to include 1,200 patients testing the pill against mild disease.

MSN did not respond to a request for comment.

INDIA TRIALS

Merck, whose shares closed down 1.6% at $80.63, has entered into voluntary licensing agreements with at least eight Indian drugmakers for molnupiravir, with an aim to turn the South Asian nation into a manufacturing hub for the drug to supply low- and middle-income nations.

Five of the eight Indian companies – Dr Reddy’s Laboratories, Cipla, Sun Pharma, Torrent Pharmaceuticals and Emcure Pharmaceuticals – are conducting a joint trial for the antiviral drug only in mild COVID-19 patients in an outpatient setting.

The other licensed company, Hetero, in early July announced interim data from its own late-stage trial of generic molnupiravir in mild COVID-19 patients and submitted an application to regulators for its emergency use.

Hetero is separately conducting a study on moderate COVID-19 patients and has said those results will be presented at a future date.

(Reporting by Shivani Singh and Anuron Kumar Mitra in Bengaluru and Neha Arora in New Delhi, additional reporting by Deena Beasley; Editing by Caroline Humer and Bill Berkrot)

Source Link Two Indian drugmakers to end trials of generic Merck pill for moderate COVID-19

David Barret
David Barret

Related posts:

  1. Republican Cheney named as vice chair of U.S. House panel investigating Jan. 6 attack
  2. Point raises $46.5 million for its premium debit card
  3. Onin is trying to fix event planning by combining calendar and chat
  4. S&P 500 on track for worst day in four months

Filed Under: News

Reader Interactions

Leave a Reply Cancel reply

Your email address will not be published. Required fields are marked *

Primary Sidebar

  • Man Broke Down Wall In His Basement And Discovered An Ancient Underground City That Once Housed 20,000 People
  • Same-Sex Penguin Couple Adopt And Raise Chick – And They’ve All Got 10/10 Names
  • Dolphins May Not “See” With Echolocation, But Instead “Feel” With It
  • Confirmed! Comet 3I/ATLAS Is Indeed An Interstellar Visitor, Quite Different From Its Predecessors
  • At 192, Jonathan – The Oldest Living Land Animal – Has Lived Through 40 US Presidents
  • 300,000-Year-Old Wooden Tools “Made By Denisovans” Discovered In China
  • Why Do Cats Eyes Glow? For The Same Reason Great White Sharks’ Do, Silly
  • G-astronomical News: Michelin-Starred Meal To Be Served On The ISS
  • In 2032, Earth May Witness A Once-In-5,000-Year Event On The Moon
  • Brand New Microscope Designed For Underwater Reveals Stunning Details Of Corals
  • The Atlantic’s Major Circulation Current Is Showing Worrying Signs, But Is Collapse Near?
  • “The Rings Held The Answer”: How We Finally Figured Out Saturn’s Day Length In 2019
  • Mystery Of Leonardo Da Vinci’s “Vitruvian Man” Solved By A Dentist And A Protractor
  • Asteroid Ryugu’s Latest Mineral Is As Weird As Finding “A Tropical Seed In The Arctic”
  • IFLScience The Big Questions: Are We Living Through A Sixth Mass Extinction?
  • Alien Abduction Or A Trick Of The Mind? A Down To Earth Explanation Of Close Encounters
  • Six Months Into Trump’s Presidency, Americans Report Record Low Pride In Being American
  • TikToker Unknowingly Handles Extremely Venomous Cone Snail And Lives To Tell The Tale
  • Scientists Sequence Oldest Egyptian DNA To Date, From A Whopping 4,800 Years Ago
  • “Uncharted Waters”: Large Hadron Collider Begins Colliding Oxygen For The First Time
  • Business
  • Health
  • News
  • Science
  • Technology
  • +1 718 874 1545
  • +91 78878 22626
  • [email protected]
Office Address
Prudour Pvt. Ltd. 420 Lexington Avenue Suite 300 New York City, NY 10170.

Powered by Prudour Network

Copyrights © 2025 · Medical Market Report. All Rights Reserved.

Go to mobile version