Novartis' ($NVS) Bexsero, approved in 34 countries, was the world's first marketed vaccine to protect against the deadly meningitis B. And now, it's one step closer to becoming the first in the U.S.--that is, if a Pfizer ($PFE) candidate doesn't beat it to the finish line.
Tuesday, the Swiss pharma announced it had submitted its Biologic License Application to the FDA for Bexsero, which nabbed the agency's breakthrough designation in April. The regulator now has 60 days to review the filing, and it will set a final approval decision date if and when it accepts it.
"Bexsero is the result of 20 years of groundbreaking research and a testament to our leadership in preventing rare but devastating diseases," said Andrin Oswald, Novartis' head of vaccines, said in a statement. "With today's submission, we are one step closer to ensuring that no family in the U.S. has to endure the loss of a loved one from vaccine-preventable meningitis."
While negotiations over Phase III trial design previously delayed the Basel-based drugmaker's plans to file, investigational use of the vaccine on a pair of outbreak-ridden U.S. college campuses last year gave Bexsero new momentum. Novartis now has real-world safety and tolerability data from 14,000 people--a pool quite a bit bigger than the 8,000-person clinical trials that helped Bexsero win approval in Australia, Canada and Europe.
But while that may bode well for the shot's regulatory future, it could well have competition by the time it reaches the market. Pfizer, whose meningitis B candidate is also an FDA-tagged breakthrough, submitted its own application for approval Tuesday.
A market showdown won't be Novartis' concern for long, however. After years of pinning its struggling vaccines unit's hopes on Bexsero, the company in April sold off the division to GlaxoSmithKline ($GSK) for $7.1 billion as part of a blockbuster asset swap.
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