|Cardiovascular Systems Completes PMA Submission of Orbital Atherectomy System; AMAG Pharma Announces Preliminary Results from Ferumoxytol|
|By Staff and Wire Reports|
|Friday, 15 March 2013 18:46|
Cardiovascular Systems (NASDAQ: CSII), announced it has submitted its Premarket Approval (PMA) application to the U.S. Food and Drug Administration (FDA) for its orbital atherectomy system, used to treat calcified coronary arteries.
The completed PMA application marks another major coronary milestone for CSI, following the release of ORBIT II pivotal trial results at the recent 2013 American College of Cardiology (ACC) conference. CSI's technology produced clinical outcomes that exceeded the trial's two primary safety and efficacy endpoints by a significant margin—within one of the most challenging patient populations.
“Coronary arterial calcium is a vastly underestimated problem in medicine today, and there is a pressing need for a solution,” said David L. Martin, president and CEO of Cardiovascular Systems. “The ORBIT II results we shared at ACC show that our orbital atherectomy technology may be a viable treatment option for calcified coronary arteries. We look forward to working with the FDA on a potential coronary indication for this most challenging, underserved patient population.”
The company completed ORBIT II enrollment of 443 patients at 49 U.S. medical centers in November 2012. ORBIT II is evaluating the safety and effectiveness of the company's orbital atherectomy technology in treating patients with severely calcified coronary lesions. This is the first Investigational Device Exemption study in history to evaluate this problematic subset of patients. At ACC, Dr. Jeffrey Chambers of Metropolitan Heart and Vascular Institute, Minneapolis, presented data that showed a 30-day freedom from MACE (major adverse cardiac events) rate of 89.8 percent and procedural success of 89.1 percent (including in-hospital MACE).
According to estimates, moderate to severe arterial calcium is present in nearly 40 percent of patients undergoing a percutaneous coronary intervention. Moderate-to-severe calcium contributes to poor outcomes and higher treatment costs in coronary interventions when traditional therapies are used, including a significantly higher occurrence of death and MACE. Coronary approval would open up a large, underserved market opportunity for CSI, estimated to exceed $1.5 billion annually in the United States.
The FDA agreed to a modular PMA process that allowed CSI to submit the first two modules covering preclinical data and manufacturing/quality systems, while still collecting, compiling and analyzing the clinical data. CSI has now submitted the third and final PMA application module, as well as responses to FDA comments on the first two modules, which were submitted in late 2012.
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced positive preliminary data from the IDA-303 study. IDA-303 is a single arm, open-label extension study that evaluated the safety and efficacy of repeat dosing with ferumoxytol in patients with persistent or recurring iron deficiency anemia (IDA) regardless of the underlying cause and a history of unsatisfactory oral iron therapy or in whom oral iron could not be used. Patients were eligible to enroll in the IDA-303 extension study after they completed IDA-301, which was a double-blind, placebo-controlled trial that randomized patients to receive either a one gram intravenous course of ferumoxytol or placebo, the results of which were previously reported by the company and presented at the American Society of Hematology annual meeting in December 2012.
A total of 634 patients were enrolled and qualified for ongoing observation/treatment in IDA-303. Of the 634 patients enrolled in IDA-303, 471 had previously received one treatment course with ferumoxytol in the IDA-301 study, and the remainder had received placebo. Patients were eligible for ferumoxytol treatment in IDA-303 if their hemoglobin levels fell below 11 g/dL and their transferrin saturation (TSAT) levels were less than 20%. During the course of the IDA-303 study, 337 patients were treated with ferumoxytol; 151 of these patients had received placebo in IDA-301 and therefore received their first course of ferumoxytol in the IDA-303 study. A total of 244 patients received a second course of ferumoxytol, of whom 186 patients had received their first course in IDA-301. The remainder of patients enrolled in IDA-303 did not receive treatment, suggesting the durability of response to the first course of ferumoxytol administered in the IDA-301 study.
The primary efficacy endpoint of the extension study was the mean change in hemoglobin from baseline to week five following the first course of ferumoxytol. The 151 patients who received their first course of therapy in IDA-303 achieved a statistically significant mean increase in hemoglobin from baseline to week five of 2.6 g/dL. This change was consistent with the 2.7 g/dL increase in hemoglobin reported for ferumoxytol-treated patients in both the IDA-301 and IDA-302 studies.
The first secondary endpoint was the mean change in hemoglobin from baseline to week five for each subsequent course of ferumoxytol after treatment course one. The group of patients receiving a second (n=244) and third (n=69) course of treatment with ferumoxytol in IDA-303 included patients who had received ferumoxytol in IDA-301 and patients who had received their first course of ferumoxytol in IDA-303. With repeat dosing, ferumoxytol also demonstrated a statistically significant increase in mean hemoglobin from baseline to week five, with a mean hemoglobin increase of 1.5 g/dL following treatment course two and a 1.1 g/dL increase following treatment course three. The mean hemoglobin level achieved by patients at week five following each of the first three treatment courses with ferumoxytol were all comparable, with the mean hemoglobin levels in course one of 11.7 g/dL, in course two of 11.9 g/dL, and in course three of 11.4 g/dL, suggesting the consistent effect of ferumoxytol treatment with repeat dosing. Only a small number of patients (n=18) received four or more courses of ferumoxytol over the 6 month duration of the study, limiting formal analyses of these data.
No new safety signals were observed with repeat dosing of ferumoxytol and the types of reported adverse events (AEs) were consistent with those seen in both the previously reported IDA and CKD phase III studies, and those contained in the approved U.S. package insert for Feraheme; no hypersensitivity reactions or hypotension were reported in the IDA-303 study. Approximately 48 percent of patients who received ferumoxytol treatment course one in this study experienced an adverse event, consistent with the AE rate reported in the IDA-301 study; in each of treatment courses two and three, approximately 38 percent of patients experienced an AE. Approximately 5 percent of ferumoxytol-treated patients in this study experienced a serious adverse event in each of the three treatment courses, none of which were deemed related to treatment by study investigators.
Protocol-defined adverse events of special interest (AESI) for the IDA studies were defined to include mild to severe hypotension or hypersensitivity reactions or associated symptoms. There was one AESI, shortness of breath (or dyspnea), which was reported as not related to treatment in one patient who received a second course of ferumoxytol. Cardiovascular AEs, deemed not related to treatment, were reported in approximately 1 percent of ferumoxytol-treated patients in each of the three treatment courses. No deaths were reported in this study.
We are pleased to see the consistency of both the safety and efficacy data observed across the full IDA phase III program in studies IDA-301, IDA-302 and now IDA-303, said William Heiden, president and chief executive officer of AMAG. The final data from this study will be included in the registration package for ferumoxytol in Europe in pursuit of the broader IDA indication, which we expect will be filed this year.
In December 2012, AMAG submitted a supplemental new drug application (sNDA) to the United States Food and Drug Administration (FDA) for Feraheme® (ferumoxytol) Injection for Intravenous (IV) requesting FDA approval to expand the indication for ferumoxytol beyond the current approved indication for the treatment of IDA in adult patients with chronic kidney disease to all adult patients with IDA who have failed or could not tolerate oral iron treatment. This sNDA is currently under review with the FDA. Under the Prescription Drug User Fee Act (PDUFA) guidelines, the FDA has set October 21, 2013 as a target date for completion of their review.
AMAG Pharmaceuticals, Inc. (NASDAQ: AMAG) today announced positive preliminary data from the IDA-303 study.
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