FDA panel unanimously endorses Glaxo's Shingrix as $1B market duel nears

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GSK's shingles vaccine Shingrix won the unanimous support of an FDA panel on Wednesday.

Marking a big step in its march toward potential approval, GlaxoSmithKline’s shingles vaccine Shingrix won the support of an FDA panel as experts touted its strengths over Merck’s Zostavax. The shot, slated to be a blockbuster, now heads to the FDA for an October action date.

Asked whether the vaccine’s trial data support efficacy and safety, panelists voted 11-0 in favor of the Glaxo candidate. FDA officials will now take the discussion and vote into consideration as the agency works toward a final decision. GSK is seeking approval for people ages 50 and older.

While lauding its efficacy, the panelists expressed a desire for further Shingrix testing in patient subgroups that were underrepresented in trials to date.

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After the vote, GSK’s director of scientific affairs and public health for vaccines Dr. Leonard Friedland told FiercePharma the company is “thrilled” the FDA committee recognized Shingrix’s safety and efficacy. Glaxo set out 12 years ago to address an age-related decline in immunity that makes elderly people susceptible to shingles; this vaccine is a result of that work, he added.

If Shingrix passes FDA gatekeepers next month, it’s likely to shake up the market in a big way. Merck’s Zostavax is currently the only approved shingles vaccine in the U.S., and some market watchers believe GlaxoSmithKline’s product will likely steal share and drive uptake.

At the panel, one expert said Shingrix is “a lot better than the vaccine we have now.” Another called it a “major advance.” A recent report by life science commercial intelligence firm Evaluate concluded that Shingrix will reach blockbuster territory by 2022. Zostavax brought in $685 million for Merck last year.

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Leading up to the FDA action date, Glaxo has touted data showing its vaccine offers lasting protection and can provide protection for those who’ve previously received Zostavax. The vaccine is one of three new launches GSK CEO Emma Walmsley said is a near-term focus for the drugmaker.

Aside from from the FDA’s action date toward the end of October, another big date for the shot is the CDC’s Advisory Committee on Immunization Practices meeting next month. That group issues recommendations on vaccine policy for consideration at CDC, and has indicated it will vote on Shingrix during the meeting, according to a GSK spokesperson.