GlaxoSmithKline (GSK - Free Report) recently received a complete response letter (CRL) from the US Food and Drug Administration (FDA) regarding the company’s influenza vaccine candidate, Q-Pan H5N1 (pandemic influenza A virus monovalent adjuvanted vaccine).
The FDA issued the CRL due to an administrative issue. Glaxo noted in its press release that the issue has already been resolved and it is working with the FDA to gain approval.
Glaxo is looking to get Q-Pan H5N1 vaccine approved for active immunization for the prevention of disease in adults who are at increased risk of exposure to the H5N1 influenza virus subtype contained in the vaccine.
We note that in Nov 2012, the FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) voted in favor of the H5N1 vaccine unanimously (14-0). The VRBPAC found the safety and immunogenicity data on Q-Pan H5N1 to be sufficient to support approval in adults.
Glaxo has collaborated with the Biomedical Advanced Development and Research Authority (BARDA) of the US Department of Health and Human Services for the development of the H5N1 vaccine since 2006.
We note that Glaxo boasts of a strong vaccine portfolio which includes vaccines like Infanrix/Pediarix, Rotarix, Synflorix and Cervarix. In Dec 2012, the portfolio was further boosted by the US approval of its influenza vaccine, Fluarix Quadrivalent, for the prevention of influenza caused by types A and B strains in adults and children aged 3 years and above.
Glaxo, a large cap pharma stock, carries a Zacks Rank #4 (Sell). Large-cap pharma companies that currently look better-positioned include Eli Lilly and Company (LLY - Free Report) , Abbott Laboratories (ABT - Free Report) and Novo Nordisk (NVO - Free Report) . All three are Zacks Rank #2 (Buy) stocks.