Novartis AG (ADR)(NYSE:NVS) Seeks A Second Indication For Kymriah Therapy


Swiss pharmaceutical giant Novartis AG (ADR)(NYSE:NVS) is seeking an approval from the U.S. Food and Drug Administration to have its Kymriah drug allowed as indication for another type of blood cancer. Kymriah’s initial approval was granted earlier in the year and now it is seeking to be used as a treatment in adult patients suffering from refractory or relapsed DLBCL – diffuse large B-cell lymphoma and who are disqualified from getting stem cell transplants.

“Kymriah represents a historic breakthrough in the evolution of individualised immunotherapy and we are committed to bringing this innovation to as many patients who may benefit as possible,” said the chief medical officer of Novartis and CEO-designate, Vas Narasimhan, in a statement.

Acute lymphoblastic leukaemia

In August Kymriah was approved as a therapy in patients aged up to 25 suffering from acute lymphoblastic leukaemia. With more indications added Kymriah’s annual sales are expected to exceed $1 billion though there are rivals such as Yescarta which was developed by Gilead Sciences, Inc. (NASDAQ:GILD).

When Kymriah was approved in August Novartis priced it at $475,000. The pharmaceutical giant also announced that it would be giving certain patients their money back in case they didn’t respond to the treatment. Part of the reason for the high price is the fact that the pool of patients the therapy is targeting is relatively small. However with more indications it is likely the price of the drug could be reduced. Kymriah’s rival, Yescarta, is priced at $373,000 for the treatment of diffuse large B-cell lymphoma.

High manufacturing costs

Other factors contributing to the high prices of these drugs includes their high manufacturing costs as the T cells of a patient have to be collected before they are re-engineered and then reinfused into the body in order to fight cancer. Both Yescarta and Kymriah are one-time therapies and they have the potential of curing patients without having to try out other options.

Prior to make the application for the second indication for Kymriah, a study involving 27 patients was carried out in ten countries.

On Tuesday shares of Novartis rose by 1.04% to close the day at $82.58.


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