Dec 6 U.S. health regulators on Friday approved
Auxilium Pharmaceuticals Inc's Xiaflex injections to
treat a condition that causes a painful curvature of the penis
called Peyronie's disease.
It marks the second U.S. approval for Xiaflex, which in 2010
received a Food and Drug Administration nod to treat Dupuytren's
contracture - a condition in which hardening of the connective
tissue collagen in the hands bends fingers toward the palm,
leaving a patient unable to straighten their hand or use their
Auxilium shares were up more than 9 percent at $21.13 in
afternoon trading on Nasdaq.
Xiaflex is now the first FDA-approved non-surgical treatment
option for men with Peyronie's disease who have a plaque buildup
in the penis that results in a curvature deformity of at least
30 degrees upon erection, the agency said.
The drug is injected directly into the collagen buildup to
break it down in order to help restore normal function to the
penis or hands.
Cowen and Co is forecasting that Peyronie's approval will
add $100 million to annual Xiaflex sales by 2018.
Treatment for Peyronie's would consist of a maximum of four
treatment cycles, the FDA said. Each treatment cycle consists of
two Xiaflex injections directly into the collagen-containing
structure of the penis, and one penile modeling procedure - a
massaging of the treated area by a health care professional to
help further break down the plaque or scar tissue.
In clinical trials, Xiaflex significantly reduced penile
curvature deformity and related bothersome effects compared with
a placebo, the FDA said.
A potential serious side effect of treatment with Xiaflex is
penile fracture - a rupture within the penile shaft. As a
result, a condition of the approval is the implementation of a
Risk Evaluation and Mitigation Strategy (REMS).
The REMS requires participating health care professionals to
be certified by completing training in the administration of
Xiaflex for Peyronie's disease. The REMS also requires health
care facilities to ensure that Xiaflex is dispensed only for use
by certified health care professionals, the FDA said.
The most common adverse reactions associated with Xiaflex
for Peyronie's treatment include penile bruising, swelling and