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Glaxo Files for Label Expansion of Influenza Vaccine in US

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GlaxoSmithKline plc (GSK - Free Report) announced that it has submitted a supplemental Biologics License Application (sBLA) to the FDA seeking approval to expand the label of Fluarix Quadrivalent – an influenza vaccine - for infants six months or older.

At present, this vaccine is approved for active immunization against influenza A subtype viruses and type B viruses, in persons three years of age and older.

Glaxo’s shares are up 9% so far this year, comparing favorably with an increase of 6.5% witnessed by the Zacks classified Large-Cap Pharma industry.

If approved, the same dose of the influenza vaccine will be eligible for all, from the age of six months and up. The sBLA was based on positive data from a phase III pivotal study evaluating the efficacy of Fluarix Quadrivalent in children six months through 35 months of age and on two supportive studies.

At the last earnings conference call, the company mentioned Glaxo saw increased demand for Fluarix/Flulaval in the U.S. in 2016. Sales of the vaccine rose 38% at constant exchange rates in the year. If approved for the label expansion, its sales could grow further.

Vaccines is one of the leading therapeutic areas for Glaxo. Overall, vaccines sales rose 14% in 2016, contributing about 16% of Glaxo’s total sales in the year. Glaxo’s vaccine business was strengthened by the acquisition of Novartis AG’s (NVS - Free Report) non-influenza Vaccines business in 2015 for $7.1 billion. The meningitis vaccines, Menveo and Bexsero, have been performing well and are a key contributor to sales growth. Glaxo’s most important vaccine product in the pipeline is its shingles vaccine, Shingrix. Glaxo has filed a regulatory application for the vaccine in both the U.S. and EU and expects approval both in the U.S. and Europe this year.

In Oct 2015, Glaxo divested two quadrivalent meningitis ACWY vaccines, Nimenrix and Mencevax, to Pfizer, Inc. (PFE - Free Report) .

Glaxo has a Zacks Rank #2 (Buy).

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A pharma stock worth considering is Summit Therapeutics plc (SMMT - Free Report) , carrying a Zacks Rank #2. You can seethe complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.

Shares of Summit Therapeutics rose 61.2% in the past one year while loss estimates for the current year ending Jan 2018 have narrowed around 2% in the past 60 days.

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