Novartis' Tasigna gets FDA priority review for early-stage CML and Gilenia for MS; also OK for meningitis vaccine Menveo

In what was clearly a good couple of days for Swiss drug major Novartis, the company revealed last Friday that Tasigna (nilotinib) 20mg capsules has been granted priority review by the US Food and Drug Administration for the treatment of adult patients with newly-diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML) in chronic phase, meaning the drug's standard approval time will be cut from 10 to six months, and this morning stated that a like status was approved for its multiple sclerosis drug Gilenia (fingolimod; FTY720). It also said today that the agency has cleared its vaccine Menveo for active immunization to prevent invasive meningococcal disease.

According to the company, Tasigna has demonstrated that significantly fewer patients progressed to more advanced stages of the disease than the standard of care - Novartis' already-marketed drug Gleevec/Glivec (imatinib mesylate) tablets - at 12 months. Tasigna also showed a statistically-significant improvement over Gleevec in every other measure of efficacy in the trial, including major molecular response (MMR) and complete cytogenetic response (CCyR) at 12 months.

Tasigna also filed in EU and Japan