Novartis wins FDA nod for Rydapt, a new targeted drug for acute myeloid leukemia

Novartis HQ
Novartis has gotten FDA approval for Rydapt, its new breakthrough treatment for acute myeloid leukemia.

Novartis, which reported a good first quarter this week, has started the second quarter  with good news today by winning FDA approval for Rydapt, its new breakthrough treatment for acute myeloid leukemia (AML), which is expected to generate more than $250 million in annual sales in the next few years. 

The FDA said it approved midostaurin for patients that have acute AML and the specific genetic mutation called FLT3. It was approved for use with a companion diagnostic. The kinase inhibitor, which works by blocking several enzymes that promote cell growth, is approved in combination with chemotherapy. It was also approved for adults with certain types of rare blood disorders.

The drug, which bagged a breakthrough tag from the FDA last year, charted a median overall survival of 74.7 months in a Phase 3 trial, beating out the 25.6 months seen on placebo alone.

AML accounts for about 25% of all adult leukemias, according to Novartis, and has the lowest survival rate. Credit Suisse says the drug has the potential to reach $260 million in sales by 2019.

Today’s news comes as Novartis surprised some followers this week, posting better-than-expected first-quarter revenues, leading analysts to suggest the worst may be behind the company. Its new pharma products delivered particularly well, helping the Swiss drugmaker meet quarterly sales expectations with a haul of $11.54 billion.