It looks like Novartis
This isn't the first delay for cladribine. The FDA refused to accept the application last November, asking for additional information before the agency would even look at the application. Merck KGaA resubmitted the application six months ago and was supposed to hear by yesterday whether the FDA was going to approve the drug.
Cladribine has also had trouble in Europe where the European Medicines Agency issued a negative opinion of the drug in September, claiming the risks didn't outweigh the benefits.
The European decision, which Merck KGaA is appealing, led to fear that the FDA would do the same. On the surface, an extension makes it seem like the FDA might be more open to approving the drug, but the delay might just be the thorough nature of the FDA. Rejections are called "complete response letters," and if the FDA hasn't finished reviewing data submitted by Merck KGaA, its response really wouldn't be complete. Even if a rejection is coming, Merck KGaA should be willing to wait so that it knows everything the FDA wants in order to gain approval. It certainly doesn't want to get rejected for one thing only to discover the FDA has a new issue on the second attempt.
Whatever the final decision, Novartis gets at least an additional three months to pump Gilenya. While Gilenya remains free of competition in the oral multiple sclerosis drug market, it still has other competition.
Gilenya has the advantage over drugs available from Bayer, Merck KGaA, Pfizer
We'll know just how well the launch is going when Novartis releases fourth-quarter earnings early next year.
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