New Drug For Hand Contracture Disorder Gets FDA Panel Support

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Main Category: Bones / Orthopaedics
Also Included In: Regulatory Affairs / Drug Approvals;  Clinical Trials / Drug Trials;  Rehabilitation / Physical Therapy
Article Date: 17 Sep 2009 - 2:00 PDT

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An expert advisory panel to the US Food and Drug Administration (FDA) has voted unanimously to recommend federal approval of a new drug to combat the hand disorder known as Dupuytren's contracture, a debilitating condition where collagen progressively accumulates in the hand causing fingers to deform and limiting hand movement.

The FDA advisory panel voted 12 to 0 on Wednesday to approve Xiaflex, which is made by Auxilium Pharmaceuticals Inc. of Malvern, Pennsylvania, for the treatment of Depuytren's contracture.

The FDA does not have to follow the recommendation of its advisory panels, but it rarely does not.

If approved, Xiaflex, will be the only drug specifically targeting Dupuytren's disease, a progressive genetic fibroproliferative disorder which disrupts the normal production of collagen in the hand, resulting in abnormal amounts of collagen nodules in the palm.

Eventually the collagen nodules build up into cords that stretch from the palm to the finger joints, causing the fingers to be bent and unextendable. This reduces finger movement to the point where the patient can't type, cook, or even shake hands.

The new drug contains the enzyme collagenase which destroys collagen and weakens the cords. The collagenase comes from the anaerobic bacteria Clostridium histolyticum, which produces a more powerful enzyme than the human equivalent.

Millions of people all over the world have Dupuytren's, with Caucasians of Northern European ancestry being the most affected group (3 to 6 per cent incidence rate).

Dupuytren's contracture is more prevalent among men than women. Incidence increases with age, diabetes, epilepsy, smoking, and excessive use of alcohol.

The main evidence for the efficacy and safety of Xiaflex comes from a Phase 3 clinic trial where 308 patients were treated either with the collagenase drug or a placebo at various sites across the US and the results indicated the injection was safe and effective. The trial was conducted by the Department of Orthopaedics at Stony Brook University Medical Center in New York and the findings were published earlier this month in the New England Journal of Medicine.

The results showed that near normal finger motion was restored in 64 per cent of the patients who received three injections of the drug in each joint compared with 6.8 per cent of the patients who had the placebo.

The day after giving the collagenase injections, the researchers said they could manipulate the patients' fingers and break the cords causing the contracture.

The alternative standard treatment is surgery, and the results of the trial showed that contracture returned for about 4 per cent of the patients after just over 7 months which is about the same as the proportion that recurs after surgery.

According to a report in the Los Angeles Times, the panel's main concern was that doctors administering the drug are properly trained to inject it carefully into the affected joints.

If approved, Xiaflex will have the status of "orphan drug" which attracts tax incentives for research and gives the company a seven-year guaranteed position as sole provider of drugs to treat the rare condition.

Armando Anido, Chief Executive Officer and President of Auxilium said:

"We are very pleased with the Advisory Committee's unanimous recommendation, which supports our view that XIAFLEX has a favorable benefit to risk profile in the treatment of Dupuytren's contracture."

"XIAFLEX has the potential to provide an important new non-surgical treatment option for patients with Dupuytren's contracture, a debilitating hand condition severely affecting patients' quality of life," he added.

Source: Los Angeles Times, Auxilium, MNT archives.

Written by: Catharine Paddock, PhD
Copyright: Medical News Today
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