August 09, 2010

Novartis has got one more winner

Tasigna has got fast-track approval from the FDA to be used to treat Ph+ chronic phase CML (chronic myeloid leukemia).

To use the technical phrase, the FDA has approved a new indication for Tasigna (nilotinib) for the treatment of CML.

This new indication expands the use of Tasigna to to adult patients in earlier stages of the disease.

The new indication for Tasigna was approved under the FDA's accelerated approval program, which allows FDA to approve a drug to treat serious diseases with an unmet medical need based on an endpoint thought to reasonably predict clinical benefit.

The interesting thing is that while the FDA has approved the drug, in the meanwhile, the company is required to collect additional long term efficacy and safety data confirming the drug's benefit.

Thus, with this accelerated approval program, patients get to lay their hands on promising new drugs while the confirmatory clinical trials are being conducted.

One can hope that these confirmatory trials will stand transparent scrutiny and no inconvenient data will be hidden under the carpet on account of Big Pharma greed.

So, Novartis now provides the one-two punch for CML so to say: Gleevec and Tasigna.

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