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FDA approves Phase III trial of synthetic biological COVID-19 treatment

Updated: Jan 19

Source :https://www.healthcarefinancenews.com/news/covid-19-treatment-first-synthetic-biological-drug-receive-fda-approval-phase-3-trials


Jan 05, 2021 | By Jeff Lagasse, Associate Editor


Carrimycin includes antiviral, anti-inflammatory and anti-fibrosis effects in addition to its antibacterial effect.



Carrimycin has become the world's first synthetic biological drug treatment for severe COVID-19 to receive U.S. Food and Drug Administration approval for Phase III trials. Testing has shown that Carrimycin is effective in treating patients who have been hospitalized with severe coronavirus symptoms, helping them recover within 14 days from the worst impacts of the disease.


JAN 04MORE ON PHARMACY

COVID-19 treatment is the first synthetic biological drug to receive FDA approval for Phase 3 trials

Carrimycin includes antiviral, anti-inflammatory and anti-fibrosis effects in addition to its antibacterial effect.

Jeff Lagasse, Associate Editor

Carrimycin has become the world's first synthetic biological drug treatment for severe COVID-19 to receive U.S. Food and Drug Administration approval for Phase III trials. Testing has shown that Carrimycin is effective in treating patients who have been hospitalized with severe coronavirus symptoms, helping them recover within 14 days from the worst impacts of the disease. Carrimycin includes antiviral, anti-inflammatory and anti-fibrosis effects, in addition its antibacterial effect. It was originally designed to treat community-acquired infections in adults caused by sensitive bacteria. It was developed in China by the Tonglian Group using synthetic biology technology.


WHAT'S THE IMPACT?


Laboratory tests in early 2020 showed it has a strong anti-coronavirus effect, inhibiting the replication of COVID-19 in cells without causing significant side effects. The Phase III trials are building on testing carried out in China, the results of which have been recognized by the FDA.


Tonglian Group CEO Jiang Enhong called the international collaboration a "major breakthrough."


"The availability of vaccines is, of course, very important," said Enhong. "But we know there will always be people who contract COVID, which is why it is so essential we have therapeutic treatments, particularly for anyone hospitalized with a serious case of COVID-19."


Carrimycin's FDA-approved international multi-center Phase III trial will start this month and will run for six months. It will be conducted in the U.S., Argentina, Brazil, Colombia, India, Mexico, Peru, Philippines and Ukraine. However, the locations could be adjusted as the pandemic evolves. The trial will involve 300 patients, half in the experimental group and half in the control group.


Patients take two Carrimycin tablets a day, and the medication stored at room temperature. The course is 14 days for severe cases and around seven days for moderate cases. A seven-day course currently costs $5,355.


THE LARGER TREND


While new treatments are encouraging, it will be the development and distribution of vaccines that hold the potential for the most impact in preventing the spread of the coronavirus.


Just days before Christmas, the Department of Health and Human Services and the Department of Defense announced they will purchase another 100 million doses of Pfizer's COVID-19 vaccine. Officials are confident that this deal will ensure that there are enough vaccines available for every American who wants one by June 2021


Under the agreement, Pfizer will manufacture and distribute the 100 million doses to government-designated locations. At least 70 million doses will be delivered by the end of June 2021, with the remaining doses to be delivered by the end of July.


Last week, CareFirst BlueCross BlueShield announced that costs associated with all FDA-authorized COVID-19 vaccines will be fully covered for all members, including members in self-insured plans.


Initial vaccine supplies are expected to be limited. Most states will distribute the vaccines in phases, using Centers for Disease Control and Prevention recommendations to determine which populations will be vaccinated during each phase. As vaccines become more widely and readily available, each state will communicate when and where vaccinations will occur.


Throughout the public health emergency, it's important to continue practicing social distancing behaviors such as wearing a mask, staying at least six feet apart and washing one's hands.


Twitter: @JELagasse

Email the writer: jeff.lagasse@himssmedia.com

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