Redsey, who has high hopes, has recently had a new dynamic. On March 24, the U.S. FDA’s website showed that Gilead Sciences’ new antiviral drug, Redsywe, was granted an orphan drug, and that the disease is coronary virus disease (COVID-19).
What is an orphan medicine?
Orphan Drug, a drug specifically designed to cure (cure) or treat/control rare diseases. Rare diseases are diseases in which the number of people who are sick is 0.65 per 1,000 per 1,000 per 1,000 per 1,000.
However, according to the situation of their own countries, there are some differences in the criteria for the identification of rare diseases. For example, the United States defines diseases with fewer than 200,000 people, and Europe defines diseases with a incidence rate of less than 1/2000. There is no clear definition of rare diseases in China, but there is a general consensus that diseases with an adult prevalence rate of less than one in half a million and a incidence of less than one in 10,000 newborns can be defined as rare diseases.
In addition, because of the small number of rare patients and the high cost of research and development of new drugs, pharmaceutical research and development companies are often reluctant to invest heavily in research and development for rare diseases in order to consider profits and return on investment.
To encourage drugs for rare diseases, the FDA began in 1983 by providing a green channel for research projects targeting orphans to speed up the approval process.
Notably, under the Orphan Medicine Act of 1983, the FDA offers pharmaceutical companies that develop “rare disease” therapies for a seven-year market period that protects them from patents. During this period, the drug is produced and sold exclusively by the original research and development company, and the FDA will no longer approve other drugs with the same adaptation certificate to market, and applications for generic drugs will be banned. In addition, it will provide preferential tax incentives, special research and development fund funding, rapid review policy, new drug application fee waiver, assistance in drug research and experimental design.
In other words, Remdesivir’s FDA certification of orphan drugs means that Gilead will have exclusive protection of Redsie, and the seven-year market-exclusive period further prevents other generic drug makers from offering anti-genericdrugs.
It should be emphasized that the identification of orphan drugs does not represent the approval of the market, the drug market still must be confirmed by clinical trial data to confirm its therapeutic effect and drug safety.
Redseyway, who has high hopes,
Redcivir was originally used to fight Ebola virus infection, but its effect was not significant. As early as 2015, the FDA granted Ridsiewe an orphan drug for the treatment of Ebola virus indications, but was ultimately not approved because of the failure of a phase III clinical trial of Redciewe to treat ebola virus. After the outbreak of new coronary pneumonia, researchers found that animal models demonstrated that the drug had in vitro and in vivo activity on similar lybs such as MERS and SARS, and was therefore highly santicipated in treating the new coronavirus.
On January 21st the Wuhan Virus Institute of the Chinese Academy of Sciences filed a Chinese invention patent for Remdesivir’s use in the fight against the new coronavirus, a practice that sparked widespread controversy.
On February 1, the New England Journal of Medicine (NEJM) reported in a short report on the first successful cure in the United States of a new type of coronavirus pneumonia. According to the article, the infection with the new coronavirus deteriorated after isolation treatment, and the effect was immediate after the use of Redcivir.
At the time, Ridsywe was not approved in the United States, based on the principle of “sympathetic medication” (meaning that, in addition to clinical trials, drugs that were still in the research phase were given to patients with serious or life-threatening diseases). This is a principle commonly adopted by the international community in the face of a major outbreak, and was used by doctors in the treatment of the first confirmed patient, with no significant effect.
On February 3rd, Redsiewe was in China with a clinical phase III study, both of which were randomized “double-blind trials” and the results are expected to be announced in early April.
On the afternoon of February 5, the Ministry of Science and Technology’s emergency attack “Redsiwe Treatment 2019 New Coronary Virus Infection Research” project launched at Jinyintan Hospital in Wuhan City, the opening meeting of relevant experts said that the first batch of new coronary virus infection pneumonia patients will receive medication on February 6.
Currently, nine countries, including South Korea, Japan and France, have initiated clinical trials for Redsiewe to treat new coronary pneumonia. But it’s worth noting that while Ridsiewe has shown promise to fight coronaviruses, there is no guarantee that clinical trials will pass.
In contrast, the path of approval of the 2003 special drug shows that the first special-effects drug in China to treat SARS, the human anti-SARS-specific immunoglobulin, was introduced on July 28, 2003, but was approved for emergency use on August 9, 2004.
Perhaps as Zhao Youbin, senior intellectual property consultant and project director of Zito Intellectual Property Group, put it:
Even if ridsienthas have the status of an orphan drug, it only accelerates approval at all stages of clinical trials and still needs to go through a rigorous clinical trial process before it can be finally available.