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FDA awards Bexsero vaccine Breakthrough Therapy designation

Bexsero, the meningitis B vaccine created by Novartis that was offered to all undergraduate students over the course of the past four months, has received  Breakthrough Therapy designation in the United States from the Food and Drug Administration.

The drug received the new designation on Monday, which will allow for an expedited review, after an announcement last week that the company was filing an application for FDA review in hopes of obtaining a license.

According to a press release on Novartis’ website, the Breakthrough Therapy designation “is intended to expedite the development and review of new medicines that treat serious or life-threatening conditions.”

The FDA declined to comment and Novartis declined to be interviewed for this article.

The Centers for Disease Control and Prevention, which sponsored the emergency use authorization of the vaccine at the University, has not shared any of the data collected from the vaccine clinics with the FDA, CDC spokesperson Jason McDonald said.

“What [the] CDC did during the vaccination clinics at Princeton was monitor for adverse events,” McDonald said. “Any safety data or clinical research data is provided by the manufacturers to FDA, and that’s what FDA uses to base its decisions.”

Despite the fact that the upgrade in the drug’s designation comes months after initial use at the University and the University of California at Santa Barbara, McDonald said he did not think the use of the drug at either university had an effect on the FDA’s decision.

However, Yevgeniy Feyman, a research fellow at the Manhattan Institute, a healthcare policy research institute, said there was a “100 percent” chance that the use of the drug at the University and UCSB had an effect on the new designation.

“Because Breakthrough Therapy is so kind of elastic, it’s not very well defined,” he said. “The FDA does have a bit of discretion, so they’ve looked at the fact that CDC has pretty much said that Bexsero is safe and has been safely used by over 8,000 people, and said, ‘That’s all the clinical evidence we need.’ It may be that internally they also looked at use in other countries. So we don’t know how exactly they came to that decision, but it’s certainly possible that use at [Princeton and] Santa Barbara did contribute to it.”

Likewise, Feyman said that he does not think the drug would have gotten the designation without the outbreaks at the University and UCSB since the outbreaks showed an “unmet medical need” for the drug.

“Without evidence of any kind of outbreak, men[ingitis] B occurrence is fairly low in the U.S.,” Feyman said. “So absent these highly public outbreaks, I don’t think the FDA would have seen it as an unmet medical need necessarily.”

Feyman explained that the new designation should cut down on approval time significantly.

With the Breakthrough Therapy designation, the FDA can use “clinically significant endpoints” when evaluating the drug, which Feyman said makes the process easier. Feyman explained that the FDA can use a smaller sample size rather than test for safety or efficacy in a very large group.

Bexsero is already approved in Europe, Canada and Australia, and UK regulators recently voted to include the vaccine in the country’s National Immunisation Programme, which would allow for routine use of the drug for infants after two months of age, the press release said.

Though the vaccine has not yet been approved in the United States, Novartis has provided nearly 30,000 doses of the drug to both the University and UCSB following an outbreak in which eight University students and four UCSB students were diagnosed with a strain of meningitis B.

Bexsero is the second meningitis B vaccine to receive the Breakthrough Therapy designation in the last month. The other drug, bivalent rLP2086, manufactured by Pfizer, was granted Breakthrough Therapy designation on March 20.

“We want to have as many drugs out there for men[ingitis] B or any other disease as possible,” Feyman said, noting the benefits of price competition. “You also want to have a variety of drugs because it might be the case that one drug works for some people but not others … The FDA is kind of recognizing that it’s good to have a wide range of drugs for the same treatment.”

Associate news editor Paul Phillips contributed reporting.

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