Radcivir is approved as orphan medicine in the United States, which is expected to have a seven-year exclusive period

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 Radcivir is approved as orphan medicine in the United States, which is expected to have a seven-year exclusive period


On March 24, Beijing time, according to the database on the official website of the US Food and drug administration, remdesiver, an antiviral therapy under development developed by Gilead Sciences, was approved as an orphan drug design with the indication of coronavirus disease 2019 (covid-19).

What is orphan medicine? Orphan drugs originally refer to some drugs specially used to cure or treat / control rare diseases. Rare diseases are defined in the United States as diseases with fewer than 200000 people (or less than 1 / 5000 of the population).

In general, the R & D cost of rare disease drugs is high, and the price after marketing is also high, but the return of enterprises is not necessarily rich. Therefore, in the pursuit of profit and return on investment, pharmaceutical companies are not inclined to research and develop for applicable diseases or rare diseases with too few patients. In order to encourage the research and development of drugs for the treatment of neglected rare diseases, the US FDA began to provide a green channel for research projects on orphans in 1983, accelerating the approval process.

At the same time, orphan drug identity can provide pharmaceutical companies with a 7-year exclusivity period on the indications, that is, no pharmaceutical factory can copy the drug for treatment in the approved indications field within 7 years. In addition, in the process of drug development, pharmaceutical companies can also obtain tax credits related to qualified clinical tests, as well as other concessions such as the reduction of specific fees when submitting new drug applications.

In the face of novel coronavirus, Reed West Wei, developed by Gillie science, is considered to be a new hope to seize the throat of new coronavirus, thus making this research stage and not yet complete clinical drug become the focus of attention.

In March 23rd, novel coronavirus science issued a statement saying that the new request for coronavirus in Europe and the United States has been urgently requesting Reed Siweis personal sympathy request (compassionateuse) to increase exponentially in recent weeks, which has overwhelmed the system of gilded emergency treatment access.

In order to simplify the process of emergency access, Gilead is currently transitioning from individual requests for sympathetic medication to extended use projects. Gilead said that this method can not only speed up the access of patients with severe cases to receive radcivir, but also collect data of all patients involved.

Gilead said that during this transition period, due to the large demand for medication in the past few days, new requests for personal compassionate medication could not be accepted. Except for pregnant women and children under the age of 18. Gilead will focus on processing previously approved requests and launch the extended use project within the expected time.

It is worth noting that Gilead is currently developing six clinical trials to test the efficacy of ridcivir in the treatment of different types of covid-19 patients. Among them, two clinical trials in China are expected to get results in April.

(function() {(window. Slotbydup = window. Slotbydup| []). Push ({ID: u5811557, container: ssp_, async: true});}) (); source of this article: the first financial responsibility editor: Li Xi