UPDATED: Novartis has a win some, lose some day with Gleevec

Company withdraws application from EU, then FDA approves new use
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Novartis had one of those days that starts off not looking so good and then something comes along to turn things around.

It began Friday with the European Medicines Agency letting the world know that Novartis ($NVS) had withdrawn its application for Ruvise (imatinib) which would have been marketed as Ruvise for pulmonary arterial hypertension. The drug had been under review for nearly a year. The company told the EMA that it was ditching the application since it couldn't get additional data to answer questions from the agency's Committee for Medicinal Products for Human Use (CHMP) in the required time frame. The EMA said it could apply again later.

Imatinib, which is best known as Gleevec, is one of the revolutionary drugs that has transformed some blood cancers into chronic illnesses rather than death sentences. It has been approved for multiple indications and last year it brought in nearly $4.7 billion in revenue for Novartis, $1.7 billion from the U.S. The EU approval would have added one more indication and some additional sales to the Swiss company's top line. Its patent goes off in 2015 in the U.S. and 2016 in the EU and Novartis would like to get as much from it as it can before then.

Then later in the day, Novartis learned that is exactly what would happen. The FDA announced that it has approved Gleevec to be used with chemotherapy to treat children newly diagnosed with Philadelphia chromosome positive (Ph+) acute lymphoblastic leukemia (ALL), the most common type of pediatric cancer. ALL affects about 2,900 children in the U.S. annually.

This is good news for Novartis, but the company is already planning for the drug's demise. It has been pushing its replacement therapy, Tasigna, in hopes of keeping patients within its drug-selling fold when Gleevec falls off patent. Novartis is conducting discontinuation trials in hopes of proving the newer drug has even more healing heft and so patients should take it instead.

- here's the EMA release (pdf)
- here's the FDA release

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