FDA approves Auxilium’s Xiaflex therapy

By Jyotsna Ramani on 09/24/2009 – 1:37 pm PST -- Biotech

FDA advisory panel has backed and given a green signal to Auxilium Pharmaceutical’s experimental Xiaflex therapy which cures Dupuytren’s contracture. The FDA panel has stated that the Xiaflex therapy is absolutely effective and safe and a better alternative to surgery as a treatment for a condition that affects the connective tissues in the hand. With this approval by FDA, Auxilium’s share prices have been stable for sometime as investors are waiting for what’s the next step, to make sure they have invested in the right place at the right time.
This is not only a good news for Auxilium Pharmaceuticals but also for those patients who are suffering from Dupuytren’s condition as so far surgery is the only way to resolve this condition. However, with Xiaflex therapy coming into the picture things will be better and different for patients. It is estimated that around 14 million people suffer from this condition, where they are unable to extend their fingers normally due to problems in the connective tissues.
Auxilium’s Chief Executive Armando Anido said that they are really pleased with the advisory committee’s recommendations and also stated that Xiaflex has the ability to come out as the new nonsurgical treatment option for patients suffering from Dupuytren’s contracture which has seriously affected many people around the world and their quality of life as well.
The Food and Drug Administration panel has clearly voted 12-0 which was in the favor of Xiaflex which is capable to treat the hardened connective tissues in the hands. Though FDA usually follows the advice of advisory panels, this time the decision was taken by a panel of outside experts who responded positively to marketing approval of Xiaflex therapy.
Currently, it is estimated that there are more than 100,000 patients in the Europe and United States of America who are undergoing the surgical treatment, and Xiaflex therapy is a boon for such patients. Another giant biotech company, Pfizer Inc. is collaborating with Auxilium to seek approval for Xiaflex in European countries.
Revealing more about their innovative therapy treatment, Auxilium stated that Xiaflex will loosen collagen deposits in the hand which later forms into tight cords which makes it difficult for patients to extend their fingers normally. The company further stated that they are also looking to make use of Xiaflex therapy for frozen shoulders and penile disorder called Peyronie’s disease. However, they don’t expect FDA to approve Xiaflex for these disorders for at least next few years.

FDA advisory panel has backed and given a green signal to Auxilium Pharmaceutical’s experimental Xiaflex therapy which cures Dupuytren’s contracture. The FDA panel has stated that the Xiaflex therapy is absolutely effective and safe and a better alternative to surgery as a treatment for a condition that affects the connective tissues in the hand. With this approval by FDA, Auxilium’s share prices have been stable for sometime as investors are waiting for what’s the next step, to make sure they have invested in the right place at the right time.

This is not only a good news for Auxilium Pharmaceuticals but also for those patients who are suffering from Dupuytren’s condition as so far surgery is the only way to resolve this condition. However, with Xiaflex therapy coming into the picture things will be better and different for patients. It is estimated that around 14 million people suffer from this condition, where they are unable to extend their fingers normally due to problems in the connective tissues.

Auxilium’s Chief Executive Armando Anido said that they are really pleased with the advisory committee’s recommendations and also stated that Xiaflex has the ability to come out as the new nonsurgical treatment option for patients suffering from Dupuytren’s contracture which has seriously affected many people around the world and their quality of life as well.

The Food and Drug Administration panel has clearly voted 12-0 which was in the favor of Xiaflex which is capable to treat the hardened connective tissues in the hands. Though FDA usually follows the advice of advisory panels, this time the decision was taken by a panel of outside experts who responded positively to marketing approval of Xiaflex therapy.

Currently, it is estimated that there are more than 100,000 patients in the Europe and United States of America who are undergoing the surgical treatment, and Xiaflex therapy is a boon for such patients. Another giant biotech company, Pfizer Inc. is collaborating with Auxilium to seek approval for Xiaflex in European countries.

Revealing more about their innovative therapy treatment, Auxilium stated that Xiaflex will loosen collagen deposits in the hand which later forms into tight cords which makes it difficult for patients to extend their fingers normally. The company further stated that they are also looking to make use of Xiaflex therapy for frozen shoulders and penile disorder called Peyronie’s disease. However, they don’t expect FDA to approve Xiaflex for these disorders for at least next few years.

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