On Friday, the Food and Drug Administration expanded the label of Merck's
Label expansions are useful to expand the population that a drug is used for. It might increase the drug's usage from a second-line treatment to a front-line treatment, as CV Therapeutics
But are there that many parents or young woman who would have shunned the vaccine because it only protected against cervical cancer, but will now get the vaccine because it protects against three cancers?
The label expansion could help Merck in a competition with GlaxoSmithKline's
What could expand Gardasil's usage is if Merck gets label expansions for older women or for men. Expansion into older women, for which Merck received an FDA set back earlier this year, might be a tough sell for insurance companies. But getting it approved for use in young men and boys could be possible, since the vaccine also prevents against genital warts, which affect both sexes.
Merck is expecting to sell between $1.4 billion to $1.6 billion worth of Gardasil this year, so we're not talking small potatoes. However, that is down from bigger potato projections of $1.9 to $2.1 billion earlier this year. Unfortunately, this label expansion isn't likely to contribute much to boost sales back up, in my opinion.
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