May 16, 2022

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Hospital Seeks Emergency Approval for Israeli COVID Drug

2 min read

The Ziv Medical Center in Safed has sent a letter to Nachman Ash, the Director-General of the Health Ministry, requesting him to give emergency authorization for Amor 18. The anti-COVID drug had been developed by an Israeli firm Amorphical for the treatment of patients in serious to moderate condition because of the coronavirus. Recently, the biotech company had published what it claims are promising results from the clinical study of Amor 18, which is at its second stage. The first stage of the study had been conducted at Ziv, Ichilov Hospital in Tel Aviv and Assaf Harofeh in Be’er Yaakov. 

During this stage, all patients who had been administered the drug were able to recover from the coronavirus and had been released from the hospital. The drug is either to be taken under the tongue, or inhaled. 37 patients had been recruited by the Ziv Medical Center for participating in the second stage and these were in moderate to serious conditions. Eighteen of the patients had been given the drug in question, while the remaining 19 had received a placebo. All patients who had been given Amor 18 were able to recover from the virus and were eventually discharged from the hospital.

As for the remaining 19 patients, two of them died and six of them saw their conditions deteriorate, eventually requiring them to be transferred to the ICU. Ziv Medical Center’s head of geriatric department, Dr. Nashat Abu Saleh said in the letter to Ash that Amor 18 had also been given to two patients in critical condition who hadn’t qualified for the trial through compassionate use. The condition of both the patients improved subsequently and they were released from the hospital later. If emergency authorization is granted, it would definitely be rare because Israeli health authorities usually rely on the Food and Drug Administration (FDA) in the US for giving approval of such drugs. 

However, doctors at the Ziv Medical Center were confident that a fast-tracked and special Israeli approval could be given to Amor 18. Abu Saleh said in the letter that in light of the spread of the fifth wave and the unequivocal results of the drug in terms of efficacy and safety, they would be grateful to get a permit for administering the drug to all the patients who were hospitalized. The trial for Amor 18 is expected to expand to medical centers in Europe and the United States soon. They are currently waiting for the approval from ANVISA, the Brazilian Drug Administration. 

On January 3rd, Israel had started distributing the first COVID-19 pills to at-risk patients with the coronavirus. This was a few days after the landing of first shipment of the Paxlovid pills by Pfizer at the Ben Gurion Airport. The pill is designed for treatment of high-risk patients of the coronavirus over the age of 12 and is administered at home. Pfizer had informed the FDA that in a trial of 2,250 patients, the pill had helped in cutting down hospitalizations and deaths by almost 89%. 

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