Sobi receives European marketing approval for Xiapex to treat peyronie’s disease

BioSpecifics Technologies Corp, a biopharmaceutical company developing first in class collagenase-based products marketed as Xiaflex (collagenase clostridium histolyticum or CCH) in the US and Xiapex in the EU, announced that Swedish Orphan Biovitrum AB (Sobi) has received approval from the EU Commission to market Xiapex for the treatment of adult men with Peyronie’s disease with a palpable plaque and curvature deformity of at least 30 degrees at the start of therapy.

As Dr Frankin Kuehhas mentioned: “This is great news for our patients. This is the first conservative treatment protocol which has proven its worth in high quality trials. We will start offering the Xiaflex treatment at London Andrology immediately”

The even better news for UK patients is that the cost is also significantly lower than the US with the current cost of Xiaflex being £600 per injection.

A treatment course consists of a maximum of 4 treatment cycles. Each treatment cycle consists of 2 Xiaflex injection procedures and one in-office penile modeling procedure. The second Xiaflex injection procedure occurs 1 to 3 days after the first. The in-office penile modeling procedure is performed 1 to 3 days after the second injection of the treatment cycle.  After the third office visit of each treatment cycle, the patient performs approximately 6 weeks of daily, at-home penile modeling activities.

Up to 4 treatment cycles (for a total of 8 injection procedures and 4 modeling procedures) may be administered per plaque causing the curvature deformity. If the curvature deformity is less than 15 degrees after the first, second or third treatment cycle, or if the healthcare provider determines that further treatment is not clinically indicated, then the subsequent treatment cycles should not be administered

If you would like more information on Xiaflex/Xiapex or our Peyronie’s disease treatment options please do not hesitate to contact us.