Wednesday, February 16, 2022

Eli Lilly monoclonal antibody Covid drug received FDA authorization

A new monoclonal antibody drug has become available in the U.S., as the Food and Drug Administration (FDA) authorized Ely Lilly's bebtelovimab for use in non-hospitalized Covid patients who are at a high risk of severe complications from the virus.

The move comes only weeks after the agency pulled authorization from another monoclonal antibody treatment produced by Eli Lilly - along with a drug produced by Regeneron - since they were deemed to be ineffective against the Omicron variant.

This drug showed effectiveness against the strain that now makes up nearly 100 percent of active cases in the U.S., though, and will soon begin to be administered to infected patients.

Monoclonal antibody drugs were considered to be the top treatment for the virus after a person was already infected, though administering the drugs is very resource intensive so officials have instead showed preference towards antiviral pills like molnupiravir and Paxlovid in recent weeks.

'Today's action makes available another monoclonal antibody that shows activity against omicron, at a time when we are seeking to further increase supply,' said Dr Patrizia Cavazzoni, director of the FDA's Center for Drug Evaluation and Research, said in a statement.

'This authorization is an important step in meeting the need for more tools to treat patients as new variants of the virus continue to emerge.'

The United States has already purchased 600,000 doses of the drug for $720 million, which will be distributed for free to Americans in need. The deal was pending FDA authorization.

Before July 31, the U.S. is allowed to purchase 500,000 more doses at a pre-arraigned price.

Trials for the drug included two parts, one with a low risk and one with a high risk population group.

The low risk group included 380 people, and the drug was tested alone and alongside other similar drugs. The FDA reports the trials found a 'sustained' resolution of symptoms among people who received the drug.

A second trial for high risk individuals included 150 patients. There was no placebo group in this trial, with half the patients receiving bebtelovimab alone and half receiving it mixed with another drug.

The drug was effective at preventing hospitalization and death from Covid in the high risk group as well, and it is equally effective when used alone as it is when used along with another available monoclonal antibody drug.

Monoclonal antibody drugs were the most effective treatment against the virus until very recently when more effective, easier to administer, antiviral pills began to hit the market.

The antibodies are still valuable tools, though. The drugs pump a person's body full of virus fighting antibodies that are similar to those generated by vaccination or natural immunity from previous infection.

Those antibodies then assist a person's immune system in stopping the virus from replicating and neutralizing infected cells.

The drugs have been a favorite of some conservative politicians like former President Donald Trump and Florida Gov Ron DeSantis.

Monoclonal antibody drugs do come with some major downsides. Some experts believe a focus on them, especially in conservative circles, has given the indication that the drug can replace the vaccines - which the FDA notes is not the case.

Administering the drugs can be a challenge for hospitals as well, especially during times where they are near capacity due to case surges.

A patient receiving the drugs requires constant monitoring and also a lot of tubing and machinery. Monoclonal antibodies are also significantly more expensive than the vaccines.

The FDA pulling the drugs last month for being ineffective against Omicron was a controversial decision that DeSantis described as 'authoritarianism'.

The agency stood by its decision, though, and has no brought Eli Lilly's monoclonal antibodies back into the mix with this recent authorization.


Could antihistamines help with long COVID?: Scientists launch study after healthcare worker took pills by accident and her symptoms eased

Antihistamines could provide relief for millions of people suffering from the painful and debilitating symptoms of long COVID that can be so severe that daily life can be affected.

The effects of COVID-19 on individuals can range from mild symptoms to several weeks of illness, but various ailments including brain fog, joint pain and fatigue can last for months after the initial infection - collectively known as long COVID.

The realization that antihistamines could provide some relief came by chance after two otherwise healthy, active middle-aged women with long COVID found that the pills helped.

Both women, who have not been identified, were taking over-the-counter antihistamines to treat other conditions.

The first woman, a healthcare worker in her 40s, triggered a dairy allergy by eating cheese, and the second woman had run out of the allergy medication she usually took, and experienced improved cognition and far less fatigue the following morning.

In the first instance, the woman with long COVID-19 was unable to do exercise and would suffer from chest pain, headaches, a rash and bruising, while the second had to deal with joint and abdominal pain, as well as the rashes and lesions known as 'COVID toes.' She is believed to have been one of the first people in the United States to fall ill with COVID.

In the first case, after accidentally eating some cheese about six months into having long COVID she took a 50 mg pill of the antihistamine diphenhydramine, and suddenly noticed her fatigue had virtually disappeared.

The woman did not take another antihistamine for 72 hours; when her symptoms reappeared, she took the medication and again found relief.

Her doctor then prescribed a daily antihistamine dosage that significantly reduced her long COVID-19 symptoms. She ultimately reported she had regained 90 percent of her pre-COVID-19 daily function. Nine months later, she is said to be still doing well.

In the second case, the woman took a different over-the-counter antihistamine as a substitute for what she had taken for years to manage her seasonal allergies.

She noticed that her long COVID-19 fatigue and overall cognition had improved. She also continued to take it daily together with other allergy medicine.

The second woman also found that she significantly reduced her additional long COVID-19 symptoms regaining 95 percent of her overall functioning, prior to contracting the illness.

Both cases were examined by nursing scholars at the University of California, Irvine with the findings published in the Journal for Nurse Practitioners.

'Patients tell us they wish more than anything that they could work and do the most basic activities they used to before they got sick with long COVID. They are desperately searching for something to help them get back on their feet,' said report author, Melissa Pinto, associate professor of nursing at UC Irvine to UCI News.

'Currently, there is no cure for [for long COVID], only symptom management. A number of options are being tried, with antihistamines being one of them. The possibility that an easy-to-access, over-the-counter medication could ease some of the symptoms should offer hope to the estimated 54 million people worldwide who have been in distress for months or even years.'

If correct, it would tally what had been found in earlier studies including those documented in the Journal of Investigative Medicine and Pulmonary Pharmacology & Therapeutics, which also showed similar benefits to using antihistamines to treat long COVID.

'Most patients tell us that providers have not recommended anything that has helped. If patients wish to try over-the-counter antihistamines, I urge them to do so under medical supervision. And because providers may not know about new potential treatments, I would encourage patients to be active in their care and consider taking research and case reports like ours to appointments with providers so they can help create a regimen that will work,' Pinto said.

'The next steps for this research into antihistamine treatment are to conduct broad-based trials in order to evaluate efficacy and to develop dosage schedules for clinical practice guidelines.'


Astonishing list highlighting what's REALLY causing Covid-19 deaths in Australia: 'It wasn't Covid that claimed their lives'

There were 2,639 Covid-related deaths nationally between March 2020 and January 31 - of which 2,556 (96.8 per cent) had an underlying health condition - according to new figures from the Australian Bureau of Statistics.

There were 32,000 deaths from heart disease in Australia in that period, with Covid deaths making up only one per cent of all fatalities nationwide.

Another 100,000 died from cancer during those 22 months.

'We're not overplaying the situation and we're not ignoring the victims,' the 2GB host said. 'But these records expose the overblown scare campaign we've witnessed.

'Ninety-two per cent had other underlying health issues - an average of three [underlying health issues] per person. It wasn't Covid that claimed their lives.'

Those underlying health issues ranged from pneumonia to kidney infection or chronic heart illnesses, according to the ABS data.

Fordham said the health advice during Australia's lockdowns of 2020 and 2021 should have focused more on countering one of the worst Covid co-morbities- obesity.

'Why aren't we warning people that one of the biggest risk factors is carrying around too much weight,' he said. 'Were we worried about fat-shaming?'

The US, where 16 states have obesity rates of higher than 35 per cent, has the world's highest Covid death rate with 947,895 fatalities.

The 2GB host said it wasn't 'overplaying the situation' to say the new records expose 'the overblown scare campaign we've witnessed'




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