Posted 20 April 2012
By Alexander Gaffney
Swiss pharmaceuticals manufacturer Novartis AG received mixed news from European and American regulators on 18 April, with the European Medicines Agency (EMA) approving its multiple sclerosis drug GIlenya with some additional warnings, and the US Food and Drug Administration (FDA) demanding a phase III trial for its hepatitis C drug alisporivir be halted after safety concerns were raised.
EMA's decision on GIlenya came after some concerns about the drug's safety were raised, which had led some to believe the drug might not receive approval from the European regulatory body. The drug, used to treat adults with highly active multiple sclerosis, was associated with cardiovascular-related adverse events and at least one sudden and unexpected death occurring in a US patient.
EMA said in a statement "there is clear evidence of the benefit of Gilenya in relapsing-remitting multiple sclerosis," but that given the product's known cardiovascular risks, the product must come with warnings to discourage its use in patients with heart conditions.
News of the potential blockbuster's approval was tempered by FDA's demands that Novartis halt a phase III of its hepatitis C drug alisporivir after patients were reported to be suffering from pancreatitis and one trial participant died.
The company has not yet determined if the patient's death was related to taking alisporivir, reported The Dow Jones Newswire, but FDA has ordered the trial be put on hold until the case is properly investigated.
EMA's Decision on Gilenya
EMA - European Medicines Agency gives new advice to better manage risk of adverse effects on the heart with Gilenya
EMA - European Medicines Agency gives new advice to better manage risk of adverse effects on the heart with Gilenya (Q&A)
Reuters - New warnings on Novartis MS pill in Europe and U.S
PharmPro - Novartis makes changes to label of MS drug
Wall Street Journal - Setback for Novartis Hepatitis Drug
Bloomberg - Novartis halts hepatitis drug trial after death
BioCentury - FDA places hold on alisporivir Phase III trial