Auxilium Pharmaceuticals, Inc. (NASDAQ: AUXL), a specialty biopharmaceutical company, today announced that it has received marketing approval from the U.S. Food and Drug Administration (FDA) for XIAFLEX™ (collagenase clostridium histolyticum), a novel, first-in-class, orphan-designated, biologic, for the treatment of adult Dupuytren's contracture patients with a palpable cord. The Company expects to begin shipping XIAFLEX to its distribution partners in early March in advance of a launch planned for late March.

Hope this helps.

God bless us all.

"The FDA has approved the first drug for the progressive hand disease known as Dupuytren's contracture -- the injectable collagenase clostridium histolyticum (Xiaflex).

The biologic drug, manufactured by Auxilium Pharmaceuticals of Malvern, Pa., breaks down excess collagen that builds up in the hand, preventing preventing the fingers from relaxing and straightening normally.

In announcing the approval, the FDA noted that until now the only effective treatment for the condition was surgery, which often entails a long recovery with physical therapy.

Drug approval was based on data from two randomized, double-blind, placebo-controlled, multicenter trials of 374 adult patients who had not received surgical treatment on a selected primary joint within 90 days of the first injection, and who did not use anticoagulation medicine within seven days of the study.

The primary endpoint in both studies was a reduction of joint contracture by five degrees after up to three injections. Patients in the collagenase group outperformed placebo, with 64% meeting endpoint in all joints versus 7% in placebo group in Study 1, and 44% versus 5% in Study 2.

Serious side effects of the collagenase drug include tendon rupture and ligament damage that can prevent a finger from fully bending and may require surgery to correct.

Other side effects include swelling, bruising, bleeding, and injection site pain.

Patients using anticoagulants other than low-dose aspirin should avoid using collagenase clostridium histolyticum, according to the prescribing information".


5 DEGREES?

The goal of the trials was a 5 degree improvement - absolutely insignificant in practical terms. And Auxilium is still talking thousands of dollars for treatment. Will insurers pay for this? If I were at an insurance company making this decision I'd be saying "wait a minute..."

Compared to surgery, the side effects of Xiaflex are minor. I had some pain and bruising after NA, too.

Auxilium may or may not be able to get the high price they're talking about. Their attitude seems to be that as long as it costs less than surgery, insurers will pay (and as usual there's no thought of people without insurance). But I think that if they're going collect as much money as for a surgery, they'll need to deliver roughly equivalent results.

I am scheduled for surgery 24 Feb for Dupuytren's on my left hand. Does anyone know how long it will be before Xiaflex injections are available to doctors? My doctor indicated it might be a while. Insurance companies probably take their time deciding if they want to cover a procedure. Does anyone have knowledge of this?
Having 2nd thoughts about surgery.
Thanks