Preos, AKA NPS558, is already approved in Europe for Osteoporosis. NPS has an agreement with Nycomed who sell Preos in Europe for them. Its call Preotact in Europe, but its still Preos.
In the US, Preos was not denied, but rather given an approvable letter. An approvable letter is an official notification from the FDA that contains conditions that must be satisfied prior to obtaining final U.S. marketing. The FDA wanted NPS to do an additional study on the elevated calcium levels in the body after taking Preos. The study would cost millions which at the time, NPS did not have that type of money. It was decided to focus on Gattex instead of doing another Preos study since Gattex Phase III study was underway and that drug was closer to approval.
Listed below is from a 2006 press release on the Preos Approvable letter.
March 10 /PRNewswire-FirstCall/ -- NPS Pharmaceuticals,
Inc. (Nasdaq: NPSP) announced today that the U.S. Food and Drug Administration
(FDA) has determined that the company's new drug application (NDA) for
PREOS(R) (parathyroid hormone [rDNA origin] for injection) is approvable. The
FDA indicated that the company's pivotal study with PREOS demonstrated
significant fracture risk reductions in postmenopausal women with
osteoporosis, but noted the higher incidence of hypercalcemia with PREOS
compared to placebo. The agency expressed concern regarding hypercalcemia
associated with the proposed daily dose of PREOS and has requested additional
clinical information. The agency also requested additional information
regarding the reliability and use of the injection device for delivery of the
drug.
NPS has requested a meeting with the FDA to address these issues and to
determine whether existing data are sufficient to respond to the agency's
concerns or whether additional studies will be required. Subsequent to these
discussions, NPS will be better able to project the timing for approval and
launch of PREOS.
About PREOS
PREOS is recombinant human parathyroid hormone (PTH). NPS has studied
PREOS in a number of clinical settings to document its safety and effects on
bone. The pivotal Phase 3 study, known as TOP (Treatment of Osteoporosis with
PTH), was a multi-center, randomized, double-blind and placebo-controlled
clinical trial designed to evaluate the potential of PTH to reduce the risk of
first and subsequent vertebral fractures in post-menopausal women.
In the TOP study, PREOS demonstrated a statistically significant reduction
in the risk of new vertebral fractures in women with and without pre-existing
osteoporosis-related fractures. Results from the TOP study have been the
foundation of both the E.U. and the U.S. marketing authorization applications.