Pharma News – 18 June 2020

USFDA revokes the special status given to Hydroxychloroquine for treating Covid-19

In March 2020, the US^[1] president, Donald Trump began to advocate the use of Hydroxychloroquine and azithromycin for treating Covid-19. His persuasive speech backed up by his claim of taking Hydroxychloroquine regularly won the trust of the entire country.

This subsequently increased the demand for the antimalarial drug, Hydroxychloroquine and led to the FDA^[1] approving its use for Covid-19.

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Hydroxychloroquine had received the emergency approval by late March 2020. During this period, 30 million doses of this antimalarial drug were donated to the US by two foreign drug manufacturers. This was sent to most of the US hospitals to treat the Covid-19 patients who weren’t enrolled in the clinical trials. 

However, in a recent turn of events, the FDA has revoked this status owing to the side effects produced by Hydroxychloroquine. On 15 June 2020, the FDA affirmed that antimalarial drugs, Hydroxychloroquine and Chloroquine, are ineffective in treating Covid-19. This is supported by the lack of evidence in its effectiveness and also by the increased cardiac complications experienced by the ones consuming it.

This decision was criticized by Trump as he claimed that he felt great despite consuming Hydroxychloroquine regularly. He further added that countries like Spain and France had shown great reports after using this drug. But he did not produce any evidence to back this statement. France, however, had already stopped the use of Hydroxychloroquine for Covid-19.

The FDA has also censured the combination of Hydroxychloroquine and Remdesivir for treating Covid-19. This is because Hydroxychloroquine reduces the effectiveness of Remdesivir. The emergency use of Remdesivir was authorized in May 2020. The FDA also added that Hydroxychloroquine would no longer be shipped to state and local health authorities for treating Covid-19. This antimalarial drug can however be used for the other conditions for which it is normally prescribed.

The main reason for this action was the adverse effects produced by Hydroxychloroquine. These include heart rhythm problems, severely low blood pressure, muscle or nerve damage. As of 15 June 2020, the FDA had apparently received around 390 reports citing the complications faced on consuming this drug. Out of these, 100 alone included severe cardiac complications. Recent studies have also revealed the lack of potency of Hydroxychloroquine in treating Covid-19.

Abbreviation:   1. United States

• Food and Drug Administration

AstraZeneca’s Covid-19 vaccine will provide protection for 1 year

Pascal Soriot, CEO^[1] of AstraZeneca has recently announced that the company’s vaccine will most likely provide protection from Covid-19 for 1 year. The drug firm is also planning to supply 2 billion doses of this vaccine by the end of 2020.

On May 2020, Oxford University had announced the start of Phase II/III clinical trial of its Covid-19 vaccine. This vaccine is called AZD1222 and is being tested on around 10,000 volunteers. AstraZeneca had begun production of this vaccine after the positive results were obtained in the initial stages of this trial.

To ensure supply chains across the globe, the company has also decided to collaborate with many other drug firms and enhance its manufacturing capacity. On this note, it signed agreements with the UK, the US, the CEPI^[2] and Gavi the Vaccine Alliance for producing 700 million doses. It has also licensed the Serum Institute of India for the production of another 1 billion doses, especially for low- and middle-income countries. Recently, the company struck an agreement with Europe’s Inclusive Vaccine Alliance to deliver 400 million doses of this vaccine by the end of 2020.

Abbreviation: 1.Chief Executive Officer

                              2.Coalition for Epidemic Preparedness Innovations

Dexamethasone to be used for Covid-19 treatment in the UK

On 17 June 2020, the UK government authorized the use of dexamethasone for treating critical Covid-19 patients in the country. Dexamethasone is now being prescribed for all hospitalized Covid-19 patients who are on ventilators and oxygen support.

The clinical trials to evaluate the efficacy of Dexamethasone was conducted by Oxford University. This trial was carried out in around 1,77,000 patients and was a part of the 2.1 million pounds Randomized Evaluation of COVid-19 thERapY (RECOVERY) trial. This RECOVERY trial funded by the UK government revealed the effectiveness of Dexamethasone in reducing the mortality rate of serious Covid-19 cases.

It involved the use of 6 mg Dexamethasone once a day for 10 days or till the patients is discharged. As per the results announced on 16 June 2020, this drug significantly reduces the death rate of Covid-19 patients on oxygen support by 20% and those on ventilators by 35%. It however did not have any effect on the patients who were not on oxygen support. The reports also revealed that around 2104 patients were randomized to Dexamethasone while around 4321 were randomized to standard care alone.

Based on these results, the UK government has included Dexamethasone as a part of the standard treatment of Covid-19. It has also been added to the UK government’s parallel export list. This bans the selling of Dexamethasone meant for treating UK patients to companies in other countries even at higher prices.

Dexamethasone is an anti-inflammatory steroid that is widely available and inexpensive. This drug is a steroid and is thus banned in competitions by the World Anti-Doping Agency (WADA). However, it can be used outside of competitions especially for therapeutic purposes.

References:

^[1] – USFDA revokes the special status given to Hydroxychloroquine for treating Covid-19 The Guardian – 16 June 2020

^[2] – astrazeneca-covid-19-vaccine-National Herald  – 17 June 2020

^[3] – steroid-dexamethasone-The Hindu – 17 June 2020