Novartis to submit Bexsero to FDA in Q2

The use of Bexsero to quell meningitis B outbreaks at two U.S. universities has given Novartis ($NVS) safety data from 14,000 people, but also convinced the Swiss drugmaker it cannot keep shipping the vaccine under investigational use. Novartis has now outlined its plan to make Bexsero more widely available, starting with a submission to FDA in the second quarter.

Center for Biologics Evaluation and Research director Dr. Karen Midthun revealed the anticipated timing of the application in a letter to USA Today. Novartis confirmed it intends to file for a U.S. license for Bexsero in a statement sent to FierceVaccines. In the statement, Novartis vaccine chief Dr. Andrin Oswald said the company continues "to work with the FDA to have [Bexsero] licensed in the U.S. as quickly as possible."

Plans to file in the U.S. were previously delayed by negotiations over the Phase III trial design, but the use of the vaccine at Princeton University and the University of California, Santa Barbara, has given the talks fresh momentum. Novartis also now has real-world safety and tolerability data from the 14,000 people vaccinated at the campuses. The clinical trials that helped Bexsero win approval in Australia, Canada and Europe gave the vaccine to 8,000 people.

Novartis can now draw on this data as it tries to win approval in the U.S. and expand use in Australia, Canada and Europe. The Australian Technical Advisory Group on Immunisation recently recommended Bexsero for use in young people, and the country is considering adding the vaccine to its national schedule. In the United Kingdom, the Joint Committee on Vaccination and Immunisation (JCVI) is due to give final advice on Bexsero by March 26.

JCVI's interim report expressed doubts about the cost-effectiveness of Bexsero, but was given additional evidence to review at its meeting last month. Since the interim report, a series of mainstream media articles, questions in the U.K. Parliament and campaigns by meningitis charities have raised the profile of Bexsero.

- read the letter to USA Today
- here's Novartis' release