EXCLUSIVE FOR BURSA - STUDY ON FAVIPIRAVIRTerapia Cluj will be making the first anti-Covid treatment in Romania

English Section / 16 martie 2021

Terapia Cluj will be making the first anti-Covid treatment in Romania

Over the last year, the global topic has been the Covid-19 pandemic and the potential treatments which could be administered in the event of getting infected with this virus. Controversies on the topic are many, and in many countries various treatments are administered.

Favipiravir is one of the drugs being prescribed in certain countries, brought to Romania by Terapia Cluj. In fact, the Cluj-based drug manufacturer has begun the technological tests for producing Favipiravir, an antiviral used against influenza in Japan, in Romania. CEO Dragos Damian, expects production will start in three months.

He said: "Favipiravir is widely used all over Asia, it comes from Japan and usually Japanese drugs don't always make it to the EU, but on the other hand they are widespread in Asia. It is a drug developed as an anti-influenza antivirus. It's been about ten years since it's been developed in Japan and it has proven efficiency in clinical studies against Sars-Cov-2.

Basically, we are talking about a drug repositioned from the treatment of the influenza virus infection to the treatment of Sars-Cov-2 infection. To date, it has been used on about 150 million people worldwide to treat Sars-Cov-2. In Romania, from the data we have, about 20,000 patients benefited from Favipiravir, from the quantities we brought in.

We have run some technological packaging tests, we are waiting for the results of some studies, there are certain studies that we are conducting, to make them available to the Drug Regulator Agency and normally, in three months we should be able to start production, because we also have orders from abroad, so it is also an export opportunity for Romania".

Favipiravir is currently used only in hospitals, but Terapia Cluj has begun the process to make it available in drugstores, via prescription. Dragoş Damian also told us: "There is a discussion about making it available in drugstores. The problem at the moment is the risk, as has happened before, that people who want to use it will go to the drugstore and stock up on it. It is a very bad habit that Romanians have. This drug can only be sold via prescription and cannot be given prophylactically, the buyer must have a Covid-19 diagnosis. I talked to the authorities to allow physicians to prescribe it and to have it available in drug stores, exclusively via medical prescription".

Terapia recently announced the entry into the country of a new batch of 1,165,000 tablets of FluGuard (Favipiravir), used in the treatment of COVID-19, according to the national treatment protocol. Those doses are distributed to medical units designated to treat COVID-19 patients through Alliance Healthcare.

To date, Therapy has delivered record amounts of FluGuard to hospitals in Romania, and over 25,000 patients with mild to moderate forms of Covid-19 have been successfully treated by Romanian doctors with this antiviral.

Furthermore, the company will maintain its commitment to ensure access to FluGuard treatment and to meet the immediate needs of patients hospitalized and diagnosed with COVID-19 in Romania.

Study by Terapia Cluj: "Only 0.4% of patients had serious adverse reactions to Favipiravir"

According to a study made by Terapia Cluj, which we have investigated exclusively, side effects following the administration of Favipiravir are generally light; just 0.4% of patients have had serious adverse reactions.

The quoted study states: "After use on more than 4,000 patients included in clinical trials, the common adverse reactions reported were: gastrointestinal issues, increased uric acid, decreased neutrophil count, increased aspartate aminotransferase and alanyl aminotransferase, psychiatric reactions, increase in triglyceride levels. Overall, 0.4% of patients experienced severe side effects and 1.1% discontinued treatment due to side effects. Low doses and high doses of favipiravir have the same side effect profile. This medicine is not recommended for women who are pregnant, may be pregnant or are breastfeeding."

Chronology of Favipiravir use, according to the study carried out by Terapia Cluj which BURSA received.

in April - August 2020, Japan donated Avigan (Favipiravir) to more than 80 countries for evaluation in clinical trials in the amount needed to treat 20 or 100 patients;

on June 13, 2020, the Romanian Ministry of Foreign Affairs and the Ministry of Health announced the receipt of a donation from the Government of Japan, consisting of a batch of 12,200 Avigan tablets, which will treat 100 patients interned in university centers of Bucharest, Timisoara and Cluj;

Although Favipiravir has proven efficacy and tolerability in 9 quality clinical trials with published results so far, being recommended for investigational administration in clinical trials in the US and Europe only, locally produced Favipiravir generics are already used in Russia, China, Turkey and India for the treatment of COVID-19;

since 2020, Favipiravir is included in the COVID-19 treatment protocol in Turkey, Russia, Saudi Arabia, Thailand, Kenya and 4 Indian states;

in December 2020, Avigan was not authorized in Japan for the treatment of COVID-19, as the results of the studies published in October were inconclusive;

Fujifilm announced in February 2021 the resumption of the clinical trial for Avigan, for a new attempt to get it authorized at the end of 2021;

in Romania, Favipiravir has been included in the Protocol for the treatment of SARS-CoV-2 virus infection, starting with August 2020, being a therapeutic alternative for cases where other antivirals are not available.

since October 2020, Terapia has facilitated the access of Romanian patients to treatment via Favipiravir, by providing a total amount of over 3 million FluGuard tablets (Favipiravir 200 mg), to a number of 33,000 patients;

The publication of the results of 32 clinical trials is expected in 2021, in order to clearly determine the benefits of Favipiravir in treating COVID-19: seven in Europe, five in the UK, one in Australia, two in the US and 17 in the rest of the world.


Terapia Cluj also intends to bring Ivermectin to Romania

"The discussion is for this drug to be only distributed in hospitals and under medical supervision only"

Ivermectin, like Favipiravir, is a drug used in the fight against Covid, but it is not approved in Romania, although over 20 countries use it.

Regarding ivermectin, Dragoş Damian told us: "Ivermectin is approved in the European Union in Bulgaria, the Czech Republic and Slovakia and in at least 20 other countries globally it is in part of the Sars-Cov-2 protocol. We are waiting for an approval from the authorities so that we can bring in a certain quantity of it to be distributed in hospitals, so that the doctors can perform tests and see if the results are positive and then the authorities will probably authorize it. There is still inconclusive data, regulators have not yet issued a favorable opinion, except in the aforementioned countries and until these controversies are clarified, we will not be able to bring it to Romania. A response is expected from the World Health Organization in about four weeks, and the approvals in Romania will also depend on this seal of approval from the WHO, but also on the Romanian authorities and whether they decide to include it in the therapeutic protocol which also includes Favipiravir. If they include it in the protocol, then things could speed up. The discussion is for this drug to be only distributed in hospitals and under medical supervision only."

Terapia recently announced that it is ready to deliver 200 million tablets of Ivermectin (Ivermectol) for human use every month.

Ivermectin is an antiparasitic medicine, which has been in use for over 40 years, which the WHO includes in the list of "essential medicines". This antiparasitic molecule is safe and has been used by approximately 3.7 billion people worldwide. Following the completion of clinical trials, it has been concluded that Ivermectin has significant efficacy both in the prophylaxis (pre- and post-exposure) of SARS-CoV-2 infection, as well as in all stages of disease progression. Scientific data has also shown beneficial effects, including in those most at risk (elderly persons with comorbidities, obese, institutionalized, etc.).

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