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Published on 14 June 2010

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FDA backs MS pill for further study

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Health officials in the US have said Swiss drugmaker Novartis’ first-of-a-kind multiple sclerosis (MS) pill Gilenia is safe and helps to control tremors, concentration problems and other symptoms of the condition.

Nervous system experts voted unanimously that the drug, which could become the first ever oral treatment for MS, is effective in cutting down relapses of the condition, which causes cognitive and movement problems. The US Food and Drug Administration (FDA) panel also voted 25-0 that the suggested dose appears to be safe.

There were questions, however, over possible side effects from the medication, including eye disorders, heart problems and possible weakening of the lungs. The problems proved less common among Novartis test patients given the lower of two doses but FDA scientists suggested an even lower dosage could still help patients while further cutting the risk of side effects. They voted 20-5 that research into a lower dose of the drug should be conducted by the firm.

Dr. Donald Fong, of Kaiser Permanente hospital network, said: “I’m not convinced this is the lowest effective dose. And if it’s not the lowest effective does, then why should we accept this as the final answer for the patient?”

The study, however, will only take place after the drug has been put on the market, meaning Novartis avoids a pre-approval research project which could have put a launch on hold for years. The drug is being reviewed under a priority timetable and a decision is expected in just over three months. All existing MS drugs need regular injections or infusions and some can cause flu-like side effects. Doctors say more tolerable therapies are needed to treat the condition.

Sufferers taking Gilenia in the Novartis study of about 1,200 patients experienced a 30% fall in relapse rates compared to those taking older interferon drugs such as Bayer’s Betaseron and Biogen Idec’s Avonex. But 8.5% of those taking Gilenia experienced serious side effects compared to only 5.8% taking the other medication, leading to concerns among FDA officials.

Copyright Press Association 2010
US Food and Drug Administration



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