The Commissioner of the United States Food and Drug Administration (FDA), Stephen Hahn, said that the agency is moving at “lightning speed” for the reviewing of data related to the experimental Covid-19 treatment drug from Gilead Sciences Inc. – remdesivir. This was after the use of the drug yielded encouraging results from a trial involving the drug in the US lately.
“We’re working with the company to emphasize the necessity of speed while at the same time to understand the data,” Hahn said in an interview. “There will be a lot of factors that go into all the regulatory decisions. We want to look at the totality of data to make sure that remdesivir is targeted to the right patients.”
Early trial results that were shared by the director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, on WSednesdya clearly indicated a significant effect in treating the virus with the drug remdesivir. Fauci said that the recovery period for Covid-19 patients who had been administered the drug recovered from their illness in 11 days on the average while the average recovery period for patients using a placebo was 15 days.
A decision on emergency authorization for remdesivir is going to happen “really quickly,” Fauci said during a television interview on Thursday. While he expects the FDA to take a final decision soon, the agency has not made a final conclusion on the use of the drug, Fauci said.
No timeline for allowing remdesivir to reach the market was offered by Hahn, who said that the agency has “several different pathways” which it could use to allow access. A medication can be widely approved by the FDA in addition to emergency authorization, and can then ask more study on the drug’s effectiveness be conducted even as it is used on patients.
Only one emergency authorization for a drug to be used against Covid-19 has been issued by the FDA. The use of the malaria drugs hydroxychloroquine and chloroquine in hospitalized patients were allowed by the agency last month. However, a number of analysis since then have indicated that the drugs actually did not help and could instead harm patients infected with Covid-19. Last week, the FDA even issued a warning of the drugs potentially causing heart risks.
The emergency authorization for hydroxychloroquine and chloroquine is was still supported by Hahn, who added that more data from clinical trials are still being waited. The decision “was based upon the published data and science available,” he said. “Just as in everything we’ve done in this pandemic, we’ll be flexible and we’ll adapt as data becomes available.”
The FDA has also showed some flexibility on the issue of serology tests that are able to quickly show whether an individual have positive antibodies related to the novel coronavirus pandemic. The tests have been allowed to come to market without the agency approving it.
(Source:www.bloomberg.com)
“We’re working with the company to emphasize the necessity of speed while at the same time to understand the data,” Hahn said in an interview. “There will be a lot of factors that go into all the regulatory decisions. We want to look at the totality of data to make sure that remdesivir is targeted to the right patients.”
Early trial results that were shared by the director of the National Institute of Allergy and Infectious Diseases, Anthony Fauci, on WSednesdya clearly indicated a significant effect in treating the virus with the drug remdesivir. Fauci said that the recovery period for Covid-19 patients who had been administered the drug recovered from their illness in 11 days on the average while the average recovery period for patients using a placebo was 15 days.
A decision on emergency authorization for remdesivir is going to happen “really quickly,” Fauci said during a television interview on Thursday. While he expects the FDA to take a final decision soon, the agency has not made a final conclusion on the use of the drug, Fauci said.
No timeline for allowing remdesivir to reach the market was offered by Hahn, who said that the agency has “several different pathways” which it could use to allow access. A medication can be widely approved by the FDA in addition to emergency authorization, and can then ask more study on the drug’s effectiveness be conducted even as it is used on patients.
Only one emergency authorization for a drug to be used against Covid-19 has been issued by the FDA. The use of the malaria drugs hydroxychloroquine and chloroquine in hospitalized patients were allowed by the agency last month. However, a number of analysis since then have indicated that the drugs actually did not help and could instead harm patients infected with Covid-19. Last week, the FDA even issued a warning of the drugs potentially causing heart risks.
The emergency authorization for hydroxychloroquine and chloroquine is was still supported by Hahn, who added that more data from clinical trials are still being waited. The decision “was based upon the published data and science available,” he said. “Just as in everything we’ve done in this pandemic, we’ll be flexible and we’ll adapt as data becomes available.”
The FDA has also showed some flexibility on the issue of serology tests that are able to quickly show whether an individual have positive antibodies related to the novel coronavirus pandemic. The tests have been allowed to come to market without the agency approving it.
(Source:www.bloomberg.com)
