Novartis receives approval letter for Paget’s disease treatment

The US Food and Drug Administration (FDA) has sent Novartis an “approvable letter” for zoledronic acid ? a treatment for Paget’s disease of the bone.

Approvable letters are sent by the FDA as an indication that the agency will approve a treatment, but that it requires additional information prior to doing so. It requested more information on trials investigating the use of the drug to treat osteoporosis, which are currently ongoing.

Novartis said that the drug, which it has applied for authorisation in 5mg infusions, was on course to be approved by the end of the year for sufferers of the condition. An indication for osteoporosis is expected to be submitted next year.

The drug is already approved for Paget’s disease within 41 countries under the trade name Aclasta.

Paget’s disease causes patient’s bones to breakdown, leading to deformations, fractures, arthritis and other conditions. It is thought the condition may be hereditary or caused by a slow virus.

Novartis had recently made begun to seek marketing approval for its Hepitutus B treatment telbivudine. Early phase III study results found that the drug was effective in treating the disease.

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