Novartis disclosed that it plans to submit a BLA (biologics licensing application) for Bexsero (serogroup B meningococcal vaccine) for review in the second quarter of 2014. The company won a breakthrough designation from the FDA on Monday.
Meanwhile Pfizer, which also is developing a serogroup meningococcal B vaccine, said it won breakthrough designation from the FDA in late March for its vaccine, and that it intends to submit an application for review by mid-2014.
Novartis’ Bexsero is already approved in Europe, Canada and Australia to help protect against invasive meningococcal disease caused by serogroup B.
Infections caused by MenB are uncommon in the US, but can be very serious, according to an FDA post from Karen Midthun, director of FDA’s center for biologics evaluation and research, which is working closely with Pfizer and Novartis to bring these vaccines to market.
According to the centres for disease control and prevention (CDC), 160 of the 500 cases of meningococcal disease in the US in 2012 were caused by MenB. There are vaccines licensed (approved) in the US to prevent meningitis, but none include this strain.
The FDA and CDC have since worked closely to make an unapproved MenB vaccine available as quickly as possible to the universities where CDC determined outbreaks had occurred.
Over the last four months, Novartis has provided nearly 30,000 doses of Bexsero to students and staff at Princeton University and the University of California Santa Barbara following outbreaks on their campuses. Further, the US Centers for Disease Control and Prevention (CDC) have recommended including the incoming freshman class at Princeton University in the at-risk group to receive Bexsero.
Pfizer spokeswoman Sally Beatty told us that Pfizer’s vaccine was not used at either university, though the company is holding “ongoing discussions with the FDA regarding Pfizer’s investigational vaccine candidate, bivalent rLP2086, and will continue working with the FDA to gain approval for our vaccine candidate as soon as possible.”
The Novartis vaccines were distributed under FDA’s expanded access program for investigational products. The program allows the use of unapproved drugs or vaccines to treat or prevent serious or immediately life-threatening conditions when other options are not available.
FDA medical and scientific staff still must review the data supporting the safety and effectiveness of the vaccines, as well as to inspect the quality of the manufacturing process.
The agency has a variety of regulatory tools – breakthrough therapy designation, accelerated approval, the fast-track program, and priority review – that have enabled FDA to help make innovative and effective new treatment options available to patients more rapidly for serious conditions such as MenB.