Gilead to get coronavirus drug out as soon as this week
May 05 2020
The results of United States trials of antiviral drugremdesivir for treating coronavirus are encouraging, but it is too early to celebrate, the CEO of the drugmaker's Israel branch said in an interview Monday.
Japan has following in the footsteps of the USA by announcing plans to fast track a review in to the anti-viral drug Remdesivir. "That's thanks to a lot of patients and caregivers that participate in our clinical trials". Gilead Sciences, the maker of Remdesivir, has said that it hopes to make millions of doses available by the end of the year.
The move follows U.S. authorization on Friday for emergency use of the drug for coronavirus patients.
Early trials by the University of Chicago have shown over 100 patients in an ongoing trial for the drug being taken off ventilators.
Feinmesser added that while the trial results were encouraging, "we are not celebrating yet".
Remdesivir was previously tried as a treatment for Ebola, without success.
He said that the Foster City, California-headquartered company had donated 1.5 million vials to the US government, enough to treat 150,000 to 200,000 patients.
"This medicine is really right now for the most severe patients in the hospital, and it's given by I.V.", he said.
Bell says the trial has shown that the intravenous drug can decrease the duration of symptoms by four days and there may be a mortality benefit.
The National Institute of Allergy and Infectious Disease also released the results of a study last week, which found patients treated with the drug has a 31% faster recovery time than those who received a placebo.
It was reported that those given the drugs were able to leave the hospital in 11 days on average versus 15 days for the comparison group. The drugmaker said the findings were inconclusive because the study was terminated early.
The drug's side effects include potential inflammation of the liver and problems related to its infusion, which could lead to nausea, vomiting, sweating and low blood pressure. Gilead has pledged to donate 1.5 million doses of the drug, and the stockpile now on hand will be distributed to hospitals starting on Monday, according to Vice President Mike Pence. Given through an IV, the medication is created to interfere with an enzyme that reproduces viral genetic material.
Such authorization allows "unapproved medical products" to be used in an emergency against life-threatening diseases or conditions, according to the FDA. But this drug is only for patients who are hospitalized.
Gilead did not immediately respond to a request for the price it plans to charge for the drug after those donations are used up. "We intend to get that to patients in the early part of this next week".