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CHICAGO – A new dengue virus vaccine is taking a potentially risky route to prevent mosquito-borne disease that infects nearly 400 million people each year.
Takeda Pharmaceutical Co., Ltd. plans to seek approval of the experimental vaccine first in countries where the virus is endemic, rather than starting with the United States or Europe, whose rigorous reviews are often used as a reference around the world, told Reuters of the company's executives.
This strategy is similar to that used by Sanofi SA, which in 2015 authorized the world's first dengue vaccine, Dengvaxia, in endemic markets, before attempting to obtain approval from Western regulatory authorities. , and had annual sales of one billion dollars (109 billion yen).
But the drug maker has failed to reach this target. At the end of 2017, Sanofi revealed that dengvaxia could increase the risk of severe dengue in children who have never been exposed to the virus, triggering a government investigation in the Philippines where 800,000 children of childbearing age have been exposed. to attend school had already been vaccinated.
The impact of Sanofi's vaccine has demonstrated the safety of future dengue vaccines.
Takeda officials expect a different result, hoping that their approach will prevent the setbacks suffered by Sanofi.
On Tuesday, Takeda said his vaccine was effective in preventing all four types of dengue, thus reaching the primary goal of his terminal clinical trial. The company said that no major safety issues had emerged, giving hope that this would be the next viable vaccine against the tropical virus that kills up to 25,000 people each year.
Takeda will first seek approval in each of the eight countries where his clinical trial took place: Brazil, Colombia, Panama, Dominican Republic, Nicaragua, Philippines, Thailand and Sri Lanka.
"We are still planning to start with dengue-endemic countries with a record because we think it's the most important use of the vaccine," said Derek Wallace, who runs the program. Takeda Dengue Vaccine Program.
FUTURE VACCINE
The success of TAK-003 is crucial to Takeda's vaccine ambitions, with the Japan-based drug maker integrating its $ 59 billion purchase of Shire Plc.
"The global business was based on global products and a global pipeline," said Dr. Rajeev Venkayya, president of Takeda's vaccine business, in a phone interview.
Under pressure to cut costs after the agreement with Shire, Takeda needs a strong performance from its experimental dengue and norovirus vaccines to prove the viability of global vaccine business.
"Once these two programs are declared, we will define our future," Takeda Research Director Andy Plump said last month. Venkayya is said to be encouraged by the results achieved so far.
Dengue experts wondered if Takeda's vaccine could pose similar risks to dengvax, and the results released on Tuesday were not detailed enough to provide answers.
Takeda officials said they took steps to make sure their vaccine did not have the same problems.
Takeda's TAK-003 is based on a dengue 2 virus, with genes from the other three other dengue viruses added. Dengvaxia is based on a yellow fever virus containing dengue genes. reply.
Unlike Sanofi, Takeda researchers took blood samples from the 20,000 trial participants before receiving the vaccine. This should allow them to see differences in vaccine performance among people who have already had dengue infection compared to those who did not, according to experts.
Takeda delayed the publication of his trial results for several weeks to characterize the immune response of all participants. The company expects some of these data to be published soon in a peer-reviewed medical journal.
REGRET OF SANOFI
Earlier this month, David Loew, head of vaccines at Sanofi, told FiercePharma that the company regretted having launched Dengvaxia in emerging markets before its review by the US Food and Drug Administration or the European Medicines Agency . This is the first time that Sanofi has adopted such an approach with a vaccine, he said.
"Other regulators often turn to the FDA and the EMA for their own guidelines," Loew told Reuters via email.
To share its data with endemic countries and answer questions about dengvaxie, Sanofi participated in a three-day meeting organized by the World Health Organization and the Vaccination Initiative against dengue in July 2015. Regulators from seven countries where dengue is the biggest threat, including the Philippines, were there.
Dengvaxia has since been approved in Europe for people living in endemic areas with documented previous infection. The vaccine is also under review by the FDA.
Dr. Joachim Hombach, Senior Advisor for Health at the WHO Vaccines Department, said the governments of dengue-endemic countries in Latin America and Asia are now "very sensitized" to potential risks related to dengvaxie.
"We will look at this very carefully," Hombach said of Takeda's data.
Takeda is not discouraged.
The company plans to file applications in the United States and Europe in the next year in countries where dengue fever is endemic, Venkayya said. Takeda and dengue experts are already considering ways to review the latest vaccine data with these regulators.
The Global Consortium for Dengue and Aedes-transmitted Diseases (GDAC), funded in part by drug manufacturers and working closely with the WHO, has scheduled a meeting in early March in Bangkok with regulators from at least six countries to review Takeda's findings, said Dr. In-Kyu Yoon, Director of GDAC.
Yoon said the meeting would be funded by the International Vaccines Institute, funded largely by charities and the Korean government. It is considering asking countries for a joint regulatory review similar to that in which Sanofi participated in 2015.
"Right now, there is clearly some caution," Yoon said.
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