On may 1, the Administration for quality control of medicines and food USA (FDA) approved the emergency use of the experimental drug “Ramdevpir” when treating patients infected with the coronavirus. This writes the New York Post.
The study showed that treatment with this antiviral medication can speed recovery in patients with COVID-19. The US President Donald trump made a joint statement with Dan O’day, the CEO of pharmaceutical company Gilead Sciences on approval of the drug.
“I am pleased to announce that Gilead now has emergency clearance from the FDA for the “Ramdevpir”. And you know what that means, because it was a hot news in the media lately is an important treatment for patients with the coronavirus,” said trump.
He added that he spoke with members of the group of the White house to combat the coronavirus, Dr. Anthony Fauci, Deborah birx and the head of the FDA, Steven Khan, and they all agreed that it was “a promising situation”.
“We worked together with the teams at the FDA and NIH (National institutes of health), and Gilead now in charge of this public-private partnership, whose aim is to do everything very quickly,” the President added.
“I think it really illustrates what can happen in such a short time. From the first case of coronavirus in the United States, up to today — our first step to using the therapeutic tools for its treatment — it took less than 90 days, ” said birx.
The Federal study found that treatment, “Redecision” can speed recovery in patients with COVID-19. The FDA approval expands access to the drug, allowing any doctor to prescribe “Ramdevpir” their patients with COVID-19.
But this does not mean that the product is recommended for all hospitalized patients. Still ongoing clinical trials that will determine which patients will benefit most from treatment with “Redecision”.
Dr. Anthony Fauci, Director of the National Institute of Allergy and infectious diseases, on Wednesday, April 29, said there was positive news about this drug.
Permission for the use of the drug in emergency situations is not the same as the official approval of medicines Agency.
When the Federal government declares emergency in public health, the FDA may approve drugs to address emergency situation if there is no alternative.
According to Fauci, the data showed that the “Ramdevpir” had a positive impact on accelerating the recovery time of patients.
Trump and Fauci welcomed the first results of a study on the same day when the death toll in the United States exceeded 60,000.
“This is very important because it is proven that the drug can block the virus, said Fauci. — Encouraging”.
The study involved total of 1,063 patients who were given “Ramdevpir” or placebo. The time to recovery averaged 11 days for those who received the drug, compared with 15 days for those who received a placebo.
As previously wrote ForumDaily:
According to the data, based on observations of patients, more than two thirds of critically ill patients with COVID-19 condition has improved after treatment, “Redecision”.