Glaxo's Influenza Vaccine Gets FDA Nod For Label Expansion

GlaxoSmithKline plc (NYSE:GSK) received approval from the FDA’s Center for Biologics Evaluation and Research for the label expansion of influenza vaccine — FluarixQuadrivalent. The vaccine has been approved for infants six months or older.

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

Glaxo’s shares declined 4.4% over a year as against a 19.1% rally witnessed by the industry it belongs to.

With this approval the same dose of the influenza vaccine can be used for all people, from the age of six months and up.

The company submitted a supplemental Biologics License Application (sBLA) to the FDA seeking an approval to expand the label of Fluarix Quadrivalent in March 2017. 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 also on the basis of two supportive studies.

Vaccines is one of the leading therapeutic areas for Glaxo. Overall, vaccines’ sales rose 14% in the first nine months of 2017. Glaxo’s vaccine business was strengthened by the acquisition of Novartis AG’s (NYSE:NVS) 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. Glaxo’s latest vaccine product in the pipeline is shingles vaccine, Shingrix. In October 2015, Glaxo divested two quadrivalent meningitis ACWY vaccines, Nimenrix and Mencevax, to Pfizer, Inc. (NYSE:PFE) .

Zacks Rank & Other Key Pick

Glaxocarries a Zacks Rank #2 (Buy).

Another top-ranked health care stock is Exelixis, Inc. (NASDAQ:EXEL) , which sports a Zacks Rank #1 (Strong Buy).You can see the complete list of today’s Zacks #1 Rank stocks here.

Exelixis’ earnings per share estimates have moved up from 72 cents to 73 cents for 2018 in the last 60 days. The company delivered a positive earnings surprise in all the last four quarters, with an average beat of 572.92%. Share price of the company surged 64.1% in 2017.

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