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It is a great thing that this preparation is finally available in Hungary as a product from a national manufacturer.
Mátyás Szentiványi, director general of the National Institute of Pharmacy and Food Health (OGYÉI), told the Index. Our portal was the first to write that one of the most effective drugs against coronavirus is already being produced in Hungary using steam energy: Richter has successfully solved and synthesized the active ingredient remdesivir, which is currently proving to be the most effective for the treatment of patients with severe COVID. The drugs produced so far with this drug allow the treatment of about 3,000 hospital patients. Mátyás Szentiványi also emphasized that
this is not yet available to the public because we are facing a permitting process.
The index was reported on Saturday that
Richter’s request was received by OGYÉI,
and we know there will be permission to begin clinical trials on Monday.
The drug will be available as part of the clinical trial in the hospitals where permission was requested.
The CEO said before we heard on Saturday. He also said that Richter had contacted them before and that OGYÉI had helped with the development in every way available, such as scientific advice.
Where does the approval of coronavirus drugs go?
In relation to the coronavirus, the whole world found itself in a completely new situation, according to Mátyás Szentiványi, since there was no registered drug for this disease at the beginning of the epidemic. “Consequently, the off-label use of drugs available for other diseases and the participation of patients in clinical trials have been, and continue to be, in most cases an opportunity for cure,” said the CEO.
The active substance, remdesivir, was the first authorized medicine for COVID-19 to be evaluated by the European Medicines Agency (EMA) because the active substance was new in Europe and received a marketing authorization from the European Commission. Marketing authorization.
Mátyás Szentiványi said that in Hungary, these products have priority during authorization: “we can shorten the evaluation time, but at the same time we cannot relax the professional requirements for patient safety.” During drug development, research builds on each other:
- Phase I studies are generally performed in healthy volunteers and are intended to investigate the tolerability and pharmaceutical properties of the drug;
- to II. In phase-in studies, the goal is to test the therapeutic effect in a smaller group of patients and find the effective dose;
- to III. Phase II studies are investigating the safe use of the study product in a larger group of patients, confirming results from phase I studies.
For an agent to be marketed, it must go through this development path.
– emphasized the Director General of OGYÉI.
To date, a total of 8 studies with favipiravir have been approved.
Among other things, one in which the health workers most exposed to the coronavirus receive the BCG vaccine. Thus, several preparations are already available to patients in this form, but always only in selected clinical centers, always under the supervision of the treating physician – added Mátyás Szentiványi. Test agents include agents that reduce antiviral and inflammatory processes, as well as those that target groups of patients of varying severity.
What about vaccination?
Vaccine development is currently underway around the world. According to the CEO, “this is the most important thing now, because if we close it successfully, we can say that we have defeated the virus.” He believes
It will be very important that as many people as possible are vaccinated, as this will create a flock of immunity that will allow us to put on masks and not have to follow the current strict rules.
According to him, the opinions that deny the virus and the statements that see danger and no opportunity in vaccination are very dangerous. “We must fight them with all our might.”
Prime Minister Viktor Orbán also spoke about the vaccination on Friday morning on Kossuth Radio, where he said that “we Hungarians have to endure the vaccine until at least May, but no later than June and July.”
Scarf, shawl vs. mask
Months ago, it was said that it might be enough to wrap our faces with a shawl; today it doesn’t fit. On the other hand, if I sew a mask from the same shawl, it will no longer be said. At this suggestion, the Director General said that masks made of textiles and other clothing materials do not qualify as medical devices or personal protective equipment, thus they are outside the competence of OGYÉI. However, he noted that
Protection against exhalation is more effectively provided by a professionally made fitting ear mask that covers both the nose and mouth than a scarf or shirt wrapped around the face, even if it is made exactly the same material than the latest garments, as it adheres directly to the face. more effective in preventing inhalation and exhalation.
Controlling the production of masks is not easy, since regulation, due to its different nature to medicines, takes place in the country where the manufacturer is (legally) established. “With some exceptions, production takes place outside our borders, so OGYÉI normally had the opportunity to control imports and distribution,” said Mátyás Szentiványi. These inspections are carried out in close cooperation with NAV’s customs and financial authorities.
OGYÉI has received customs alerts in more than 60 cases since the beginning of the epidemic, thus initiating procedures in almost a third of the alerts.
and in a significant proportion of them, “negative market surveillance measures have been taken against importers of non-compliant customs products, including surgical masks and other defense-related medical devices.” The Director General added that these measures involved several containers of products in some of the procedures.
(Cover image: A doctor in protective equipment treats a patient in a room set up to receive coronavirus-infected patients at the St. László Hospital in the capital on May 8, 2020. Photo: Károly Árvai / kormany.hu / MTI)
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