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Novartis withdraws application for Ruvise approval in EU

Had submitted imatinib mesylate for use in hypertension

NovartisThe European Medicines Agency (EMA) has said that Novartis has withdrawn its marketing application for Ruvise in the treatment of high blood pressure.

Ruvise (imatinib mesylate) is already available for the treatment of several cancers under the brand name Gleevec/Glivec, but Novartis has hoped to expand the drug's use by submitting it to the EMA for approval as add-on therapy for the treatment of pulmonary arterial hypertension (PAH).

However, the EMA's Committee for Medicinal Products for Human Use (CHMP) raised questions about the benefit-to-risk ratio of Ruvise during its review that current data could not answer.

“These data will not be available within the timeframe allowed in the centralised procedure,” said Novartis in its letter to announce the withdrawal of the application.

The EMA said more information about the reasons for withdrawal will be available following the next meeting of the CHMP on February 18 to 21.

Despite the application withdrawal, the fate of imatinib mesylate in hypertension is not quite sealed, and patients participating in on-going open-label extension trials and who are benefiting from Ruvise can continue treatment as per the study protocol, said Novartis.

The Swiss pharma company also ended its letter to the EMA by stating “Novartis reserves  the right to  make  further  submissions  at a  future  date  in  this  or other therapeutic indications”.

Imatinib mesylate is already one of Novartis' biggest earners as Gleevec/Glivec where it has approvals in chronic myeloid leukaemia, Ph+ acute lymphoblastic leukaemia, gastrointestinal stromal tumours (GIST), myelodysplastic or myeloproliferative diseases, advanced hypereosinophilic syndrome and dermatofibrosarcoma protuberans.

According to Novartis' 2012 financial results, the drug made $4.68bn worldwide during 2012 through sales in these indications.

However, the patent on its active ingredient is due to expire in 2014 in Japan, 2015 in the US and 2016 in the EU, and Novartis will be keen on a hypertension approval to boost the drug's sales ahead of expiration.

28th January 2013

From: Sales

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