Tag Archives: antiviral

Second smallpox drug approved by the FDA

The US Food and Drug Administration (FDA) has approved Tembexa (brincidofovir) to treat smallpox. This is the second approved smallpox drug; the first, TPOXX (tecovirimat), was approved in 2018.

TPOXX’s effectiveness against smallpox was established by studies conducted in animals infected with viruses that are closely related to the virus that causes smallpox, and was based on measuring survival at the end of the studies. More animals treated with TPOXX lived compared to the animals treated with placebo. TPOXX was approved under the FDA’s Animal Rule, which allows efficacy findings from adequate and well-controlled animal studies to support an FDA approval when it is not feasible or ethical to conduct efficacy trials in humans.

Smallpox, an acute contagious disease caused by the variola virus, was one of the most devastating diseases known to humanity and caused millions of deaths before it was eradicated. It is believed to have existed for at least 3,000 years.  

Credit: Science Museum.

The smallpox vaccine, created by Edward Jenner in 1796, was the first successful vaccine to be developed. He observed that milkmaids who previously had caught cowpox did not catch smallpox and showed that a similar inoculation could be used to prevent smallpox in other people.

The World Health Organization (WHO) launched an intensified plan to eradicate smallpox in 1967. Widespread immunization and surveillance were conducted around the world for several years. The last known natural case was in Somalia in 1977. The WHO declared smallpox eradicated in 1980, but since then many nations have expressed concerns that the variola virus, which causes smallpox, could be used as a bioweapon.

Similar to TPOXX, the FDA also approved Tembexa under its Animal Rule. Human safety data on Tembexa was based on clinical trials involving primarily patients who were treated with the drug after they received hematopoietic stem cell transplants.

In the animal study for Tembexa (brincidofovir), the efficacy was defined by measuring the animals’ survival by the end of the studies. Results demonstrated that more animals with smallpox who were treated with brincidofovir survived compared with animals who were treated with the placebo.

Hong Kong researchers say they’ve developed an antiviral coating that lasts for 90 days

The coating has been under development for 10 years, it lasts for 90 days, and a 50 ml bottle would cost around $9.

The antiviral coating could be used on commonly-used surfaces such as elevator buttons, door handles, school benches, or ATMs. Image credits: Jason Dent.

The coating, called MAP-1, can be sprayed on multiple types of surfaces, including surfaces which are often used by the public, such as elevator buttons and handrails, researchers at the Hong Kong University of Science and Technology (HKUST) say.

“These places are frequently touched, and, at the same time, serve as a very effective medium for transmission of diseases,” said HKUST Adjunct Professor Joseph Kwan, one of the chief researchers in the team that developed the product.

The coating is non-toxic for humans and the environment and has already been approved for mass consumption. The antiviral coating is expected to hit the shelves next month.

Unlike common disinfectants, this coating lasts for up to 90 days, and MAP-1 is also boosted by heat-sensitive polymers that release disinfectants when touched by humans, Kwan explains.

The coating underwent clinical tests at a Hong Kong hospital and a home for the elderly, where it proved to be efficient.

The coating is already being used against the novel coronavirus. With the help of a local charity, the non-toxic coating was sprayed in the homes of more than a thousand low-income families in the city, to help protect them against COVID-19

“I feel like it has strengthened our protection against the virus,” said Law Ha-yu, a mother of two who lives in a 110-square-foot subdivided unit that was recently sprayed with the coating.

The coating is also not very expensive. Applying the coating at an entire school would cost between HK$20,000 ($2,600) to HK$50,000, depending on the size of the sprayed area. The company also announced that smaller bottles of 50ml and 200ml will be introduced for domestic use, with prices ranging from HK$70-250 — a price that will be accessible to most households.

Hong Kong has been exemplary in its management of the coronavirus situation, completely flattening the curve and reporting only a couple of new cases for the past few days. In total, Hong Kong has had 1,038 infections despite having one of the earliest outbreaks.

First antiviral drug approved to fight novel coronavirus

The first anti-viral drug for Coronavirus disease 2019 (COVID19), also known as 2019-nCoV acute respiratory disease, has been approved for marketing by the National Medical Products Administration since the outbreak. Developed by Zhejiang Hisun Pharmaceutical Company, the drug is expected to play an important role in preventing and treating the outbreak which has now infected 70,553 in China (1,772 deaths), the government said on its official WeChat account.

COVID-19, is an infectious disease caused by SARS-CoV-2 (2019 novel coronavirus), a virus closely related to the SARS virus. The disease was discovered during, and is the cause of, the 2019–20 coronavirus outbreak.

Three potential anti-COVID19 medicines have been officially announced by the Ministry of Science and Technology: Favilavir, Chloroquine Phosphate, and Remdesivir. They all initially showed more obvious curative effects and lower adverse reactions in clinical trials.

Favilavir, formerly known as Fapilavir, an antiviral that has shown efficacy in treating the novel coronavirus, was approved for marketing, the Taizhou government in Zhejiang province announced Sunday.

It is the first anti-novel coronavirus drug that has been approved for marketing by the National Medical Products Administration since the outbreak. Developed by Zhejiang Hisun Pharmaceutical Company, the drug is expected to play an important role in preventing and treating the epidemic, the government said on its official WeChat account.

Chloroquine Phosphate is in a class of drugs called antimalarials and amebicides. It is used to prevent and treat malaria. It is also used to treat amebiasis.

The other one with the most potential – so far – has been Remdesivir, which Gilead had already been developing as a treatment for Ebola disease and Marbug virus infections. It has subsequently also been found to show antiviral activity against other single-stranded RNA viruses such as respiratory syncytial virusJunin virusLassa fever virusNipah virus, Hendra virus, and coronaviruses (including MERS and SARS viruses).

Based on success against other coronavirus infections, Gilead provided Remdesivir to physicians that treated an American patient in Snohomish County, Washington infected with 2019-nCoV, and is providing the compound to China, to conduct a pair of trials in infected individuals with and without severe symptoms.

Chinese pharma BrightGene has successfully developed and manufactured copies of the drug, it has also maintained that it will not launch the drug until it has received licensing from Gilead, conducted clinical trials and obtained approval. A study of Remdesivir in COVID-19 has already begun enrolling patients in China, with a Gilead spokesman confirming that two clinical trials will be conducted in Wuhan, the city where the first cases of the novel coronavirus were observed.