Drugs with World’s Nod, Those on Trial Amid Omicron Spur


Vaccines have largely proven to be able to do their job of preventing severe infection and hospitalisation, however, with new heavily mutated variants emerging, it continues to raise concerns about the ability of the SARS-COV-2 virus to escape antibody protection. Due to this, the need to have drugs for effectively tackling infections is seen as being key to countries’ efforts battle the pandemic.

Health regulators in the United States on Wednesday authorised the first pill against COVID-19, a Pfizer drug ‘Paxlovid’ that can be taken at home. It comes amid a swift rise in Omicron infection in US that was first detected in the country last month.

Last week, the European Medicines Agency recommended the authorization of two new medicines – casirivimab and imdevimab – against the coronavirus for people at risk of severe disease. Meanwhile, researches are underway in India to develop generic versions Covid drugs.

Recently, the AYUSH Ministry started a clinical trial to study the effect of Ashwagandha – known as a master herb in ayurvedic medicine – along with Covishield, the Covid vaccine that has been used to inoculate the majority of Indians.

Drugs Approved to Treat Covid-19 as Omicron Infections Rage

Molnupiravir

Initial data on the pill, which is taken orally, shows it can cut down hospitalisations by half. It is an oral tablet developed by Merck Merck & Co for the treatment of symptomatic Covid-19 patients.

According to a Reuters report, a World Health Organization-led program is working to provide these antiviral drugs at as low as ten dollars per course. Currently, reports suggest that countries are negotiating prices with Merck.

Molnupiravir was administered to 775 patients who tested positive for Covid-19 and only 7.3 per cent were hospitalised with fatal infection.

The United Kingdom became the first country to approve the antiviral drug Molnupiravir. Meanwhile, in India, Cipla, Dr Reddy’s, Emcure, Sun and Torrent are collaborating with Merck for clinical trials of Molnupiravir.

The United States on Wednesday authorized Pfizer Inc’s (PFE.N) antiviral COVID-19 pill for people ages 12 and older at risk of severe illness, the first oral and at-home treatment as well as a new tool against the fast-spreading Omicron variant.

Pfizer’s antiviral regimen, Paxlovid, was nearly 90% effective in preventing hospitalizations and deaths in patients at high risk of severe illness, according to data from the company’s clinical trial. Recent lab data suggests the drug retains its effectiveness against Omicron, Pfizer said.

Pfizer said it will provide an additional 2.5 million doses of its COVID-19 pill Paxlovid to the United Kingdom. A total of 2.75 million doses of the pill are expected to be delivered to the UK through 2022, the drugmaker said.

Drugs That EU Has Cleared

In a statement on Thursday, EU drug regulator said it had concluded that the monoclonal antibody treatments a combination of casirivimab and imdevimab, and the drug regdanvimab have both been proven to significantly reduce the risk of hospitalization and death in patients vulnerable to serious COVID-19.

The EMA described the safety profile of both medicines as favorable,” and said that despite a small number of side effects, the medicines’ benefits are greater than their risks.

The drug combination of casirivimab and imdevimab is made by Roche; it was granted an emergency use license by the U.S. Food and Drug Administration last November.

The EMA said both regdanvimab and the casirivimab and imdevimab combination should be offered to people over age 12 who don’t yet require oxygen support, but are at risk of worsening COVID-19. It said the combination drug can also be used preventatively. Both drugs must be administered intravenously.

Kineret

The EMA said that a drug used to treat “signs and symptoms of rheumatoid arthritis” has been cleared for treating Covid as “the medicine is considered to reduce the inflammation associated with Covid-19 and thus decrease lower airway damage, preventing development of severe respiratory failure”.

EMA said that Kineret can be used for treating Covid in adult patients with pneumonia who have to be put on low or high-flow oxygen support and are at risk of developing severe respiratory failure.

The immunosuppressive effect that Kineret has is regarded as being of help in fighting the overreaction of the immune system known as cytokine storm, which some among those severely affected by Covid are known to suffer. Kineret, EMA said, reduces the activity of the immune system and is currently authorised in the EU for the treatment of various inflammatory conditions.

Xevudy

In its statement authorising Xevudy, EMA said that it is the third monoclonal antibody recommended in the EU after Regkirona and Ronapreve and was cleared after findings that it “significantly reduces hospitalisation and deaths in patients with at least one underlying condition putting them at risk of severe Covid-19″.

Monoclonal antibody drugs involve proteins that are designed to attach to a specific target in the pathogen, or virus. When it comes to the novel coronavirus, which causes Covid-19, it is the spike protein that studs its surface and allows the virus to invade and latch on to human cells.

EMA said that Xevudy, also called sotrovimab, is recommended for use in “adults and adolescents (from 12 years of age and weighing at least 40kg) who do not require supplemental oxygen and who are at increased risk of the disease becoming severe”.

Trials on India’s Ahswagandha

The Ministry of Ayurveda, Yoga, Naturopathy, Unani, Siddha, Sowa-Rigpa and Homoeopathy (AYUSH)’s Central Council of Research in Ayurvedic Science (CCRAS) has started a clinical trial to study the effect of Ashwagandha – known as a master herb in ayurvedic medicine – along with Covishield, the Covid vaccine that has been used to inoculate the majority of Indians. The objective of the trial is to check the effects of the herb on the protection offered by the vaccine.

Dr Bhushan Patwardhan, the chairman of the interdisciplinary AYUSH Research and Development Task Force on Covid-19, said, “We are not making any tall claims but talking about scientific studies.”

The step has not been taken based on any “hypothesis”, he said, but is rooted in an earlier study that showed the herb works as an adjuvant.

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