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Pfizer gets FDA nod for meningitis vaccine Trumenba

Ahead of Novartis’ rival drug Bexsero

Pfizer headquarters Pfizer's Trumenba has become the first vaccine licensed in the US to protection meningitis B (menB), ahead of rival Bexsero from Novartis.

Trumenba - formerly known as rLP2086 - has been approved by the FDA to prevent invasive meningococcal disease caused by Neisseria meningitidis serogroup B in people aged 10 to 25, a strain which accounted for 160 of the 500 meningitis cases reported in the US in 2012.

Invasive meningococcal disease is a life-threatening illness caused by bacteria infecting the bloodstream and the lining that surrounds the brain and spinal cord. Most cases worldwide can be attributed to five N meningitidis serogroups (A, B, C, W and Y), but menB accounts for around 40% of all cases in the US.

MenB has hit the headlines in the US after outbreaks at Princeton University and the University of California, Santa Barbara, earlier this year. The seriousness of those incidents led to Bexsero - which is already approved in Europe, Canada and Australia - being used to protect students under emergency use protocols.

Approval of Trumenba is only the first stage of getting the vaccine into use in the US, and the company will now start discussions with the US Centers for Disease Control and Prevention (CDC) to see how it might slot into routine immunisation programmes, according to Emilio Emini, senior vice president of vaccine R&D.

Pfizer has already generated trial data showing that Trumenba can be safely administered alongside Merck & Co's human papillomavirus (HPV) vaccine Gardasil without compromising the effectiveness of either shot.

Both Bexsero and Trumenba were granted breakthrough designations from the FDA and were submitted for approval on the same day in the US, but Pfizer's candidate pipped its rival at the post.

Novartis will shortly be handing Bexsero over to GlaxoSmithKline (GSK) as part of a deal agreed earlier this year, while there have been a number of other asset swaps in recent months changing the landscape of the vaccine sector including the sale by Novartis of the remainder of its vaccines unit to CSL for $275m.

Pfizer recently added to its portfolio with a $635m deal to acquire two Baxter vaccines, namely its menC product NeisVac-C and FSME-IMMUN/TicoVac, which helps protect against tick-borne encephalitis (TBE).

Article by
Phil Taylor

30th October 2014

From: Sales

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