Xolair Endorsement Retracted by NICE

The National Institute for Health and Clinical Excellence (NICE) have released draft guidance withdrawing their recommendation of Novartis’ Xolair for severe persistent allergic asthma. In 2007, NICE circulated guidelines supporting the use of Xolair (omalizumab) on the National Health Service (NHS) for adults whose asthma is poorly controlled.  Then in 2011 they reject the treatment’s

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Novartis’ Afinitor Approved for Breast Cancer by FDA

Novartis announced on Friday that they have received approval from US regulators for Afinitor as a treatment for advanced breast cancer. The US Food and Drug Administration (FDA) have given the thumbs up to Afinitor (everolimus) for use with Pfizer’s Aromasin (exemestane) to treat certain postmenopausal women with advanced hormone-receptor positive, HER2-negative breast cancer.  The

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Novartis’ GIST Drug, Glivec, Receives European Commission Approval

Novartis announced earlier today that the European Commission has approved an update to their Glivec (imatinib) label to include 36 months of treatment after surgery, for adults with KIT (CD117)-positive gastrointestinal stromal tumours (GIST) who met the inclusion conditions of the pivotal study. The prolonged treatment has been demonstrated to increase recurrence-free survival and the

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Phase III Trial Confirms Safety of Novartis’ Gilenya

A few days after confirming that a patient died 24 hours after beginning treatment with Gilenya, Novartis today announced positive data from an additional major late-stage study of their multiple sclerosis drug. Results from the 1, 083-patient Phase III 2309 trial revealed that sufferers with relapsing-remitting multiple sclerosis (MS) treated with Gilenya (fingolimod) had a

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Novartis Drug Afinitor Gains EU Approval

Novartis have today announced that the European Commission has approved Afinitor (everolimus) tablets for the treatment of unrespectable or metastatic, well- or moderately-differentiated neuroendocrine tumours (NET) of pancreatic origin in adults with progressive disease. The approval was based on Phase III data from the largest clinical trial to date in advanced pancreatic NET.  The RADIANT-3

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FDA Rejects Novartis’ Gout Drug

The US Food and Drug Administration have turned down canakinumab, Novartis’ new treatment for gout.  The Swiss company has received a complete response letter from the regulators in the USA for ACZ885 (canakinumab) in gouty arthritis patients and has asked for additional information, including clinical data to evaluate the benefit-risk profile in refractory patients.  The

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Novartis MS pill rejected by NICE

The decision by the UK’s cost watchdog to reject Novartis’ Gilenya, the first pill to treat multiple sclerosis, has been greeted with dismay by the company and patient groups. In provisional draft guidance published this morning, the National Institute for Health and Clinical Excellence has decided against recommending payment by the National Health Service for

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