US regulators have issued a double whammy to Sanofi-Aventis on the same day by delaying yet again a review of its obesity drug Acomplia and further restricting the use of its antibiotic Ketek.
The Franco-German drugmaker issued a statement noting that the review period for Acomplia (rimonabant) has been extended by the US Food and Drug Administration for three months, until July 27, which represents another postponement by the agency. The FDA had been expected to give its verdict in April after it accepted Sanofi’s New Drug Application resubmission for Acomplia in December.
This time, the company gave no reason for the fresh delay but noted that it has just submitted data from its SERENADE clinical study report comparing 20mg once-daily rimonabant to placebo in improving blood sugar control in treatment-naive type 2 diabetic patients not adequately controlled by diet alone for six months.
The company has very high hopes for Acomplia and despite the presumed hesitance on the part of the FDA to review the drug, the company still believes that it can be a blockbuster, though some analysts have expressed concern about its side effects, which have included dizziness, nausea, depression and headaches.
The treatment is available in a number of European countries but chances of its success hinge on reimbursement. Sweden, Denmark, Ireland and most recently France have backed such schemes, but government advisors in Germany have recommended that the country's healthcare system should not reimburse treatment with the drug.
Two out of three ain’t good for Ketek
As if this further delay for Acomplia was not bad enough, the FDA said that Sanofi’s antibiotic Ketek (telithromycin), which the agency approved in 2004, could no longer be used to treat acute bacterial sinusitis and acute bacterial exacerbations of chronic bronchitis.
The agency said that “the balance of benefits and risks no longer support approval of the drug for these indications,” but noted that Ketek can remain on the market for the treatment of community-acquired pneumonia of mild-to-moderate severity, acquired outside of hospitals or long-term care facilities. However, the FDA has told Sanofi to add a ‘black box’ warning to Ketek’s labels, stating that it should not be used in patients with myasthenia gravis, a disease that causes muscle weakness.
The company has also been required to strengthen the warning section regarding adverse events including visual disturbances and loss of consciousness. In June last year, warnings for hepatic toxicity severe symptoms of liver disease were bolstered)
The decision came as no great surprise, given that an FDA joint advisory committee had held a two-day hearing on the drug in December and recommended that Ketek be taken off the market for the two previously-mentioned indications. The agency has also had to endure a barrage of criticism for approving the treatment in the first place from US politicians who have claimed that a major safety trial of Ketek used to support approval had "data integrity problems."
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