Britain will start to roll out Merck's molnupiravir Covid-19 antiviral pill through a drug trial later this month, Susan Hopkins, chief medical adviser at the UK Health Security Agency said on Sunday (November 7).
Last week Britain became the first country in the world to approve the potentially game-changing Covid-19 antiviral pill, jointly developed by US-based Merck & Co Inc and Ridgeback Biotherapeutics.
The government said in October it had secured 480,000 courses of the Merck drug, as well as 250,000 courses of an antiviral pill developed by Pfizer Inc.
Asked about the molnupiravir approval, Hopkins told BBC television: "That is great news and it will start to be rolled out through a drug trial in the end of this month/the beginning of December."
Hopkins said all the trials so far had been done with the unvaccinated, so this would help understand how it will work in the wider vaccinated population.
With growing concerns over the spread of Omicron variant, the UK has signed two contracts with drug majors Pfizer Inc. and Merck & Co to buy 4.25 million courses of antivirals for the NHS patients.
The move is aimed at reducing hospitalisations and easing pressures on the NHS.
The two new contracts are for 1.75 million additional courses of Merck Sharp and Dohme's (MSD) molnupiravir (Lagevrio®) and 2.5 million additional courses of PF-07321332/ritonavir (Paxlovid™) from Pfizer.
The ordered drugs will be available from early next year and both are expected to be effective against Omicron.
The recent order is in addition to the 480,000 courses of molnupiravir and 250,000 courses of PF-07321332/ritonavir procurement announced in October.
Indian drugmaker Dr Reddy's Laboratories will launch its generic version of Merck's antiviral Covid-19 pill, molnupiravir, and price it at 35 rupees ($0.4693) per capsule, a company spokesperson said on Tuesday (January 4).
The overall cost for a patient treated with a 5-day course of 40 capsules of the generic drug, to be sold under brand name 'Molflu', will come up to 1,400 rupees ($18.77).
In comparison, the treatment with Merck's pill in the United States costs $700.
"Molflu is expected to be available from early next week in pharmacies throughout (India) with particular focus on states with high caseload of Covid-19," the company spokesperson said.
India last week gave emergency use approval to along with two vaccines, as the country braces for a possible spike in coronavirus cases due to the rapidly spreading Omicron variant.
There is big gap between the healthcare facilities provided by the developing nations and developed nations. Vaccination programs help developing countries, defend deadliest of diseases. Hilleman Labs, a partner of Merck & Co. and Wellcome Trust
Researchers from the University of Oxford today (December 8) started recruiting for a clinical trial to test novel antiviral Covid-19 treatments for early use in the illness by people in the community and those who are at higher risk of complications.
Partnering with the National Institute for Health Research (NIHR), colleagues in several UK universities, and the NHS UK-wide, the Platform Adaptive trial of NOvel antiviRals for eArly treatMent of Covid-19 In the Community (PANORAMIC), is a national priority trial, and will be open to participants from across the UK.
The first treatment to be tested by the UK Antiviral Taskforce will be molnupiravir, a Covid antiviral pill already licensed by the MHRA.
Britain became the first country in the world to approve molnupiravir, which was jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics, in November.
Global demand for Pfizer's oral Covid-19 antiviral treatment Paxlovid has been unexpectedly low due to complicated eligibility requirements, reduced testing, and potential for drug interactions, according to a media report.
Demand also has been hampered by the perception that Omicron infections are not that severe.
Paxlovid was expected to be a major tool in the fight against Covid after it reduced hospitalizations or deaths in high-risk patients by around 90 per cent in a clinical trial.
Thousands of people still die from Covid-19 every week, even as global infections are far off their peak. And there are only a few proven antiviral treatments, of which Paxlovid is the most attractive. The others are Merck & Co's far less effective rival pill molnupiravir, and Gilead Sciences' intravenous remdesivir.
'Tepotinib' has been recommended by the National Institute for Health and Care Excellence (NICE) to patients with a specific gene mutation of advanced
non-small-cell lung cancer (NSCLC).
The new potentially life-extending drug is available from Thursday (14 April). It has been recommended for routine use across the NHS in England through Project
Orbis, a programme to review and approve promising cancer drugs helping patients access treatments faster.
NICE has published its final appraisal document recommending tepotinib (also known as Tepmetko and produced by company Merck Serono Ltd) as an option for treating
advanced NSCLC with METex14 skipping gene alterations in adults.
People with METex14 skipping alterations of NSCLC make up between 1-2% of all adults with lung cancer in England.
Tepotinib, which requires people to take two tablets once daily, provides a new targeted treatment for adults with METex14 skipping gene alterations. Just over 700
people in England would be eligible to receive tepotinib as either a first or second-line treatment.
The NHS has secured a deal for 'Pembrolizumab' to treat women with triple-negative breast cancer.
Up to 1,600 women a year affected by high risk triple-negative breast cancer are set to benefit from the confidential deal struck by the NHS and the Merck Sharp
and Dohme's (MSD), manufacturer of Pembrolizumab.
Triple-negative breast cancer affects around 8,000 women a year - accounting for 15% of all breast cancer cases.
This will be the 25th breast cancer treatment fast-tracked to patients through funding from the Cancer Drugs Fund and the second treatment for triple negative breast
cancer to be introduced this year on the NHS.
NHS chief executive, Amanda Pritchard, said: "This is a hugely significant moment for women - the NHS has struck a new deal to roll out a potentially life-saving
drug for patients suffering with the most aggressive form of breast cancer that has been traditionally very difficult to treat.
AstraZeneca said on Monday (June 27) two of its existing therapies were recommended for treating patients with some forms of high-risk breast cancers in the
European Union, in a boost to the company's oncology portfolio.
Lynparza, a cancer drug developed jointly with U.S.-based Merck, was backed for standalone use or in combination with endocrine therapy in adults with a form of
genetically mutated early-stage breast cancer.
The drug, which has received a similar recommendation in the United States in March, is a key asset for AstraZeneca. It was recommended in patients with low-to-normal
levels of a protein known as HER2 that is the target of several new therapies.
Enhertu - developed jointly with Japan's Daiichi Sankyo (4568.T) - was the other drug that was endorsed by the European Medicines Agency for treating an aggressive
form of breast cancer characterised by a high rate of HER2.
An alliance of companies has pledged to ensure equitable access to vaccines and treatments for pandemics, as the friction around intellectual property rights
for Covid-19 interventions between the pharmaceutical industry and developing nations endures.
At the heart of the plan is a commitment to set aside part of the production of vaccines and treatments upfront for vulnerable populations in low-income countries
when the next pandemic arises, given how fragmented access to Covid tools has left many populations unprotected.
In order to do better next time - and without knowing which companies will develop the first drugs and vaccines for the next pandemic - having the industry
collectively make this commitment is potentially transformative, said Thomas Cueni, head of the International Federation of Pharmaceutical Manufacturers &
Associations (IFPMA).
The pledge, called the Berlin Declaration, was made on July 19 by members of the global pharmaceutical industry group that include many of the companies involved
in developing Covid interventions, such as AstraZeneca, GSK, Moderna, Pfizer and Merck.
The declaration is not legally binding.
However, if a company that signed on reneges on its vow, it would face grave consequences in the court of public opinion, said Cueni.
The National Institute for Health and Care Excellence (NICE) has recommended pembrolizumab in combination with chemotherapy (paclitaxel or nab-paclitaxel)
which is said to benefit people with triple negative breast cancer.
Clinical trial evidence shows that, compared with paclitaxel, pembrolizumab combination increases how long people have before their cancer gets worse and how long they live.
NICE already recommends atezolizumab in combination with chemotherapy for untreated PD-L1-positive, locally advanced or metastatic, triple-negative breast cancer.
Atezolizumab combination is recommended by NICE for people with IC equal to or greater than 1%.
"This means that some people who can't have atezolizumab combination could be eligible for pembrolizumab combination," said NICE.
NICE's independent appraisal committee also agreed that the pembrolizumab combination meets the higher cost-effectiveness threshold for life-extending treatments for people with a short life expectancy.
Given by injection every 3 weeks, pembrolizumab (also called Keytruda and made by Merck Sharp and Dohme) is a type of immunotherapy that specifically targets triple
negative breast cancer. It works by blocking the activity of a protein known as PD-L1 which is produced in larger amounts on cancerous cells than normal cells. By blocking PD-L1 it helps the person's own immune cells to attack the cancer.
AstraZeneca on Wednesday (April 5) said a combination of its cancer drugs Imfinzi and Lynparza met the main goal in a late-stage trial in patients with
advanced ovarian cancer.
The drugmaker said treatment with a combination of those drugs, along with chemotherapy and bevacizumab - the existing standard of care - improved progression-free
survival in newly diagnosed patients with advanced ovarian cancer without certain mutations.
Lynparza is jointly developed with U.S.-based Merck & Co as a treatment for breast cancer in early stage with certain mutations. Imfinzi alone, along with
chemotherapy and bevacizumab, did not reach statistical significance in its interim analysis, the drugmaker added.
Philipp Harter, director, Department of Gynaecology and Gynaecologic Oncology, Evangelische Kliniken Essen-Mitte, Germany and principal investigator for the trial,
said: "DUO-O showcases the power of academia and industry collaboration in advancing new treatment combinations for patients with ovarian cancer. I'm grateful for
the academic cooperative study groups and patients around the world that made this trial possible and look forward to sharing the results with the clinical community."
Susan Galbraith, executive vice president, Oncology R&D, AstraZeneca, said: "While there has been significant progress for patients with advanced ovarian cancer, an
unmet need still remains. These data from the DUO-O trial provide encouraging evidence for this this Lynparza and Imfinzi combination in patients without tumour
BRCA mutations and reinforce our continued commitment to finding new treatment approaches for these patients. It will be important to understand the key secondary
endpoints as well as data for relevant subgroups."